ACR50 and ACR70 improvements were achieved in 34% and 27% of patients dosed with ABX464 50 mg, compared to 6% in the placebo group, respectively. MC Services AG 10.1136/annrheumdis-2011-200726 Currently, the study is still recruiting patients. and transmitted securely. Mild-to-moderate gastrointestinal AEs led to a high drop-out rate of patients on ABX464 100 mg, which may not be a relevant dose to use. -, Wilke T, Mueller S, Lee SC, et al. Communications Efficacy of 50mg once daily obefazimod was assessed by the DAS28-CRP remission (DAS28-CRP < 2.6[2]) and the ACR20/50/70[3] rates. Regarding the biomarkers, a significant upregulation of miR-124 expression was observed for every patient dosed with ABX464, and a decrease in IL-6 blood levels was observed in both active dose groups compared to placebo. Furthermore, we look forward to initiating, around the end of this or early next year, a phase 2a trial of ABX464 to treat Crohns disease.. In addition, a DAS28-CRP remission (DAS-CRP < 2.6) has been reported in 19% of patients dosed with 50 mg ABX464 compared to 5% in the placebo group, within the intent-to-treat (ITT) patients population. Keywords: RN: What differentiates ABX464 from other RA medications? 20/23 patients were eligible to continue their treatment after week 52 and are at present in their second year of continued daily oral treatment with 50mg obefazimod. Drug survival of second biological DMARD therapy in patients with rheumatoid arthritis: a retrospective non-interventional cohort analysis. For rheumatoid arthritis patients, there is still a significant unmet medical need for safe and durablemedicines. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. ABX464 is an oral once-daily drug candidate with a novel mechanism of action that has already demonstrated positive results in ulcerative colitis (UC), another severe chronic inflammatory disease with closely related biological etiology. Ann Rheum Dis 2012;71:15249. 60 patients who had either an inadequate response to methotrexate and/or TNF inhibitors participated in the study. LifeSci Advisors C Daien reported receiving consulting fees, punctual links, or research grants from Abivax and other sources. Key clinical point: Obefazimod (ABX464 ) at a dose of 50 mg showed promising efficacy and was safe and well-tolerated in patients with moderate-to-severely active rheumatoid arthritis (RA). More information on the company is available at www.abivax.com. Special consideration should be given to the potential hurtles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and ethics committees of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC, clinical data, Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. As I mentioned before, during the phase 2a trial, 50 mg of once daily oral administration of ABX464 showed a very favorable tolerability profile with mainly mild to moderate and transient side effects. For IBD (UC and Crohns disease), pharmaceutical sales during this same period are estimated to have reached nearly $16 billion. Conclusion: All opinions expressed herein are subject to change without notice. Rheumatoid arthritis is a severe, debilitating disease with 4.2 million diagnosed patients in G7 (US, G5 Europe & Japan) countries and pharmaceutical sales of $24.4 billion in 2018, 60-patient trial fully authorized in four European countries, ABX464 Phase 2b Ulcerative Colitis trial progressing well, ABX464 Phase 2a Crohns disease trial to start Q4 2019 or Q1 2020. 67% (40/60) of the patients who completed the induction study enrolled in the open-label extension maintenance study to receive 50mg obefazimod orally once a day for an additional year. Actifin | Two serious adverse events were reported (one on placebo group and one on ABX464 100 mg). Regina Jehle Unauthorized use of these marks is strictly prohibited. Further, the abstract on these phase 2a data has been selected for a poster presentation at the Annual European Congress of Rheumatology, EULAR 2022. This disease represents a major burden for the millions of affected patients, their families and for healthcare systems worldwide. Competing interests: CD received consulting fees from ABIVAX as PI of the study, and declares consulting fees, punctual links or research grant from Abbvie, Amgen, BMS, Fresenius-Kabi, MSD, Novartis, Pfizer, Sandoz, Sanofi, Roche-Chugai, UCB. This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the Company's programs. Osteoarthritis: OA usually affects weight-bearing joints such as the hips, knees, and spine. Detailed Description: June 29, 2020 By Michele B. Kaufman, PharmD, BCGP, ABX464 is an oral treatment that binds to the cap-binding complex (CBC), which rests on the RNA molecule. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Rooney Partners LLC 10.1136/annrheumdis-2019-216653 This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNF) therapies. The study was conducted in 21study centers across four European countries (France, Belgium, Poland and Hungary). The treatment groups were well balanced in terms of disease severity as well as patient demographics. [Adalimumab plus methotrexate for the treatment of rheumatoid arthritis: a multi-center randomized, double-blind, placebo-controlled clinical study.]. Based on the results of the Phase 2a clinical study, Abivax is planning to start a clinical phase 2b program in RA. The https:// ensures that you are connecting to the DISCLAIMER Phase IIa randomised, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with MTX, in patients with moderate to severe active RA who have inadequate response to MTX or/and to an anti- TNF therapy or intolerance to anti-TNF therapy.EUDRACT number: 2018-004677-27 TRIAL REGISTRATION NUMBER: NCT03813199. Axial Spondyloarthritis - Market Insight, Epidemiology And Market Forecast - 2032, Non-Radiographic Axial Spondyloarthritis (nrAxSpA) - Market Insight, Epidemiology And Market Forecast - 2032, Rheumatoid Arthritis - Market Insight, Epidemiology And Market Forecast - 2032, Juvenile Idiopathic arthritis (JIA) - Market Insight, Epidemiology And Market Forecast - 2032, Psoriatic Arthritis - Market Insight, Epidemiology And Market Forecast - 2032, Introduction to Rheumatic and Musculoskeletal Diseases (RMDs), EULAR 2022: Bimekizumab to Benefit Psoriatic Arthritis. Results will be forthcoming. ISSN 1931-3268 (print) The clinical induction and maintenance data in ulcerative colitis and rheumatoid arthritis underpin the potential of ABX464 to address a broad range of chronic inflammatory diseases. View source version on accesswire.com: The Phase 2a Clinical Trial with ABX464 in Rheumatoid Arthritis. The clinical induction and maintenance data in ulcerative colitis and rheumatoid arthritis underpin the potential of ABX464 to address a broad range of chronic inflammatory diseases; In G7 countries, the market for ulcerative colitis, Crohn's disease and rheumatoid arthritis is expected to grow to approximately USD 50B in 2026 We are pleased to initiate the first clinical trial of ABX464 in patients with moderate to severe active rheumatoid arthritis, the largest market opportunity in inflammatory disease. Galapagos demonstrates commitment to immunology with new data in rheumatoid arthritis at EULAR 2023. Jeanene Timberlake It has also shown a significant anti-inflammatory response in phase 2 studies in patients with moderate to severe ulcerative colitis.2. . DelveInsight is a Business Consulting and Market research company, providing expert business solutions for the healthcare domain and offering quintessential advisory services in the areas of R&D, Strategy Formulation, Operations, Competitive Intelligence, Competitive Landscaping, and Mergers & Acquisitions. Four controls per case were selected, matched for sex, year of birth, and year of inclusion in . Rheumatoid Arthritis: Interventions : Drug: ABX464 50mg Drug: Matching Placebo Drug: ABX464 100mg Drug: Methotrexate: Enrollment 60 Participant Flow . The publication of our RA phase 2a induction data in the journal ARD and the selection for a presentation at EULAR are very important for Abivax, as they scientifically validate the capacity of our drug candidate to address RA, in addition to ulcerative colitis and Crohn's disease, and therefore a broad range of chronic inflammatory diseases. DGAP-News: ABIVAX / Key word(s): Study resultsAbivax phase 2a study results of obefazimod (ABX464) in rheumatoid arthritis published in the journal "Annals of the Rheumatic Diseases" and selected for presentation at EULAR 2022 01.06.2022 / 08:00 The issuer is solely responsible for the content of this announcement.A. It is remarkable, that according to the observed cases population, 83% (19/23) and 52% (12/23) achieved even an ACR50 and ACR70 response respectively, corresponding to 48% (19/40) and 30% (12/40) according to the FAS. Women are three times more likely to be affected as men. The most recent phase 2a, clinical trial of ABX464 is examining 50 and 100 mg oral doses administered daily in combination with methotrexate.3 To be eligible for this multicenter study, adult patients with moderate to severe active RA (N=60; ages 1875 years) must have had an inadequate response to methotrexate and/or to one or more anti-TNF biologic treatments. For further details, please click here. Efficacy and safety of namilumab, a human monoclonal antibody against granulocyte-macrophage colony-stimulating factor (GM-CSF) ligand in patients with rheumatoid arthritis (RA) with either an inadequate response to background methotrexate therapy or an inadequate response or intolerance to an anti-TNF (tumour necrosis factor) biologic therapy: a randomized, controlled trial. Disclaimer. Pierre Courteillepierre.courteille@abivax.com The site is secure. The ACR20/50/70 measures a 20/50/70% improvement in the tenderness and swelling in designated joints and a 20/50/70% improvement in at least 3 of the 5 following measures: investigator's and patient's reported global assessment of disease scales, patient's reported pain scale, CRP level, healthy assessment questionnaire. ClinicalTrials.gov. NCI CPTC Antibody Characterization Program, Avina-Zubieta JA, Thomas J, Sadatsafavi M, et al. The outcome of the clinical studies conducted in UC, along with the promising results of the obefazimod phase2a induction as well as the maintenance study after one year of continued treatment in RA patients, underpin the potential of obefazimod to treat a broad range of chronic inflammatory diseases. These findings warrant exploration of ABX464 at 50 mg per day or less for treating patients with RA. The Phase IIa study displayed encouraging results in evaluating the safety and preliminary efficacy of ABX464 in combination with methotrexate (MTX) in patients with moderate-to-severe active RA who have an inadequate response to MTX or/and to an anti-TNF therapy. In June 2021, Abivax announced excellent top-line results of the induction phase of its Phase 2a clinical study of Obefazimod administered in combination with methotrexate (MTX) for the treatment of active moderate to severe RA. Ann Rheum Dis 2020;79:68599. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Major finding: A dose of 50 mg ABX464 vs. placebo was associated with numerically more severe adverse events (14.3% vs. 5%) but with no malignancies, opportunistic infections, or deaths, and a significant reduction in the Disease Activity Score 28-C reactive protein (1.41 vs. 0.60; P = .043) and Clinical Disease Activity Index Score (15.8 vs.. Zhonghua Nei Ke Za Zhi. View source version on businesswire.com: https://www.businesswire.com/news/home/20190801005785/en/, Abivax DAS28-CRP (A) and DAS28-ESR (B) mean (SEM) changes from baseline at weeks 4, 8 and 12 in RA patients who received placebo or ABX464 (50 or 100 mg) once daily (ITT set). Importantly, obefazimod did not only show a potent and rapid onset of action during the induction studies but, in both our RA and UC maintenance trials, demonstrated a durable efficacy over time. Please enable it to take advantage of the complete set of features! Prof. Claire Daien, M.D., Ph.D., rheumatologist at the University Hospital at Montpellier and principal investigator of the study, said: ?I am very excited that our phase 2a clinical data with ABX464, now obefazimod, in patients suffering from rheumatoid arthritis have been published in the prestigious peer-reviewed journal ARD and have further been selected for a poster presentation at EULAR . It is therefore critical to develop new therapeutic approaches based on completely different mechanisms of action. Phase 2a safety and efficacy study results of obefazimod (ABX464) in patients with rheumatoid arthritis (RA) published in the renowned and peer-reviewed journal Annals of the Rheumatic Diseases (ARD) and accepted for presentation at the Annual European Congress of Rheumatology, EULAR 2022, Presentation at EULAR is scheduled for June 1, 2022, at 8:40 p.m. CEST (2:40 p.m. EST) and will be given by principal investigator Claire Daien, M.D., Ph.D. (registered participants only), Obefazimod registered as an international nonproprietary name (INN) for ABX464 at The primary endpoint was the safety of ABX464; efficacy endpoints included the proportion of patients achieving ACR20/50/70 responses and disease activity scores (DAS28, SDAI, CDAI), EULAR response, DAS28 low disease activity or remission. Obefazimod is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in the completed Phase 2a and Phase 2b induction studies as well as in ongoing long-term maintenance studies in patients with moderate-to-severe ulcerative . There is undoubtedly a need for novel mechanisms of action in RA, and obefazimod might fill that void. Bethesda, MD 20894, Web Policies Disclosures: The study was supported by Abivax. LDdR, PG, HE, SB, DS and JS are employees at Abivax. If untreated, inflammation can also damage cartilage and the bones themselves, which lead to bone friction, chronic pain, as well as irreversible deformity and loss of mobility. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Make sure you never miss an article by signing up for our Rheumatology Network eNewsletter! Golimumab: Review of the efficacy and tolerability of a recently approved tumor necrosis factor- inhibitor. The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The publication of our RA phase 2a induction data in the journal ARD and the selection for a presentation at EULAR are very important for Abivax, as they scientifically validate the capacity of our drug candidate to address RA, in addition to ulcerative colitis and Crohns disease, and therefore a broad range of chronic inflammatory diseases. RN: What were the primary and secondary endpoints in the ABX464 study for patients with RA? Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. 60 patients who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNF) biological therapeutics participated in this randomized, double-blind, placebo-controlled trial. Unique Protocol ID: ABX464-302. Rheumatoid arthritis (RA) is an autoimmune, inflammatory condition that causes progressive destruction of joints. Rheumatology Network interviewed Claire Daien, MD, lead investigator of the ABX464 phase 2a study in the treatment of rheumatoid arthritis. Heliyon. Abivax S.A. Study of two doses of ABX464 in participants with moderate to severe rheumatoid arthritis [NCT03813199]. Abivax : reports excellent phase 2a clinical safety and efficacy results with 50mg ABX464 in rheumatoid arthritis 06/23/2021 | 02:01am EDT DGAP-News: ABIVAX / Key word (s): Study/Study results Most patients have only transient responses to current therapies, and very few . Trial registration name: We could observe in the phase 2a proof-of-concept study that the efficacy of the molecule to treat rheumatoid arthritis is comparable to currently available drugs. The distribution of this document may be restricted by law in certain jurisdictions. Stratgie et communication digitale : JLL CONSEIL. See this image and copyright information in PMC. This press release contains forward-looking statements, forecasts and estimates with respect to certain of the Company's programs. Would you like email updates of new search results? Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. Prof. Claire Daien, M.D., Ph.D., rheumatologist at the University Hospital at Montpellier and principal investigator of the study, said: "I am very excited that our phase 2a clinical data with ABX464, now obefazimod, in patients suffering from rheumatoid arthritis have been published in the prestigious peer-reviewed journal ARD and have further been selected for a poster presentation at EULAR 2022. Disease-modifying anti . Also, the phase 2b trial of ABX464 to treat ulcerative colitis is progressing well, with the first patient dosed expected for the next two weeks. Unable to load your collection due to an error, Unable to load your delegates due to an error. Filed Under: DMARDs & Immunosuppressives, Drug Updates Tagged With: ABX464, Rheumatoid Arthritis (RA)Issue: August 2020. +1 646 770 8858. Secondary endpoints include measures of efficacy, such as the change from baseline in the individual components of the ACR20 score, the proportion of patients who achieve an ACR20 response and the change from baseline in Disease Activity Scores (DAS) in 28 joints, among others. An official website of the United States government. About ABX464 This phase 2a randomised, double blind, placebo controlled, parallel group study evaluated the safety and efficacy of a first-in-class drug candidate ABX464 (obefazimod, 50 mg and 100 mg per day), which upregulates the biogenesis of the mRNA inhibitor micro-RNA (miR)-124, in combination with methotrexate (MTX) in 60 patients (1:1:1 ratio) with moderate-to-severe active rheumatoid arthritis (RA) who have inadequate response to MTX or/and to an anti-tumour necrosis factor alpha (TNF) therapy. Follow us on Twitter @ABIVAX_. The drug, peresolimab, is a monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1), which serves as the brakes on the immune system . Published by BMJ. The presentation will be given by principal investigator Claire Daien, M.D., Ph.D., on Wednesday, June 1, 2022 at 8:40 p.m. CEST (2:40 p.m. EST accessible for registered EULAR participants only). It commonly affects smaller joints such as those in the hands, wrists and feet, but larger joints can also be involved. Huang F, Zhang FC, Bao CD, Tao Y, Gu JR, Xu JH, Zhu P, Xu HJ, Zhang ZY, Zhao DB, Wu DH. CD: Based on the exciting data from its clinical trials in chronic inflammatory indications (UC and RA), Abivax is now working on a global phase 3 program in ulcerative colitis (to be initiated before the end of 2021), a phase 2b study in Crohns disease (also to be initiated in 2021) and a phase 2b study in RA (to be initiated in early 2022). Anne Henneckeanne.hennecke@mc-services.eu Obefazimod for Rheumatoid Arthritis. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions. *: For PP set, there were 18, 20 and 20 patients, DAS28-CRP (A) and DAS28-ESR (B) mean (SEM) changes from baseline at weeks 4,, MeSH eCollection 2023 May. 2023 Apr 28;9(5):e15839. CD: ABX464 is a highly differentiated oral drug candidate, with a novel mechanism of action based on the upregulation of a single microRNA, called miR-124, with potent anti-inflammatory properties. Objective: This site needs JavaScript to work properly. It is remarkable, that according to the observed cases population, 83% (19/23) and 52% (12/23) achieved even an ACR50 and ACR70 response respectively, corresponding to 48% (19/40) and 30% (12/40) according to the FAS. PARIS, France, June 1, 2022 08:00 a.m. (CEST) Abivax SA (Euronext Paris: FR0012333284 ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announces today that a scientific article on its phase 2aclinical study results for the treatment of moderate to severe active rheumatoid arthritis (RA) with obefazimod (ABX464) has been published in the renowned peer-reviewed journal Annals of the Rheumatic Diseases (ARD)[1]. 2019 Apr 18;21(1):101. doi: 10.1186/s13075-019-1879-x. Abivax currently focuses on the development of obefazimod for the treatment of ulcerative colitis and recently reported excellent phase 2b one-year maintenance data in this indication. +44 7413 825310, Press Relations & Investors EuropeMC Services AG Powered by Madgex Job Board Software, Wednesday, June 1, 2022 at 8:40 p.m. CEST, results of the induction phase of its phase 2a clinical study, exciting results from the phase 2a maintenance trial in RA, excellent phase 2b one-year maintenance data, https://www.accesswire.com/703500/Abivax-Phase-2a-Study-Results-of-Obefazimod-ABX464-in-Rheumatoid-Arthritis-Published-in-the-Journal-Annals-of-the-Rheumatic-Diseases-and-Selected-for-Presentation-at-EULAR-2022. Ten authors reported being current/former employees or investigators contracted by Abivax. Source: Daien C et al. ABX464-301 is a phase 2a study designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered daily, in combination with methotrexate (MTX), in patients with moderate to severe active RA who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNF) biolo. Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Abivax phase 2a study results of obefazimod (ABX464) in rheumatoid arthritis published in the journal Annals of the Rheumatic Diseases and selected for presentation at EULAR 2022. Eleven patients were withdrawn for AEs (9 patients on 100 mg, 1 on 50 mg and 1 on placebo). If this drug shows comparable positive outcomes in further clinical trials, it might become a potential therapy option for RA patients. ABX464 upregulates the expression of the anti-inflammatory microRNA miR-124 and is a first-in-class drug candidate as an oral treatment for moderate to severe RA. FAS, Full Analysis dataset; ITT, intent-to-treat. All rights reserved. ISSN 1931-3209 (online), Systemic Lupus Erythematosus Resource Center, Abx464 Enters Phase 2 Clinical Trials for RA in Europe, Rituximab-abbs Available in the U.S.; Plus Upadacitinib in Phase 3 Trials for PsA, Phase 3 Trials: Secukinumab for Psoriatic Arthritis & DA-DKP for OA, Abivax treats first patient in phase 2a rheumatoid arthritis clinical trial of ABX464, Study of two doses of ABX464 in participants with moderate to severe rheumatoid arthritis, Phase 3 Results for Olokizumab in RA Patients. Doi: 10.1136/annrheumdis-2022-222228, See more with MDedge! The study was conducted in 21 study centers across 4 European countries (France, Belgium, Poland, and Hungary). An open-access training video originally produced for a study into remote monitoring among patients with rheumatoid arthritis unexpectedly attracted more than 40,000 views within 10 months . CD: The clinical phase 2a induction study was designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered once daily (50 mg and 100 mg), in combination with methotrexate (MTX). Careers. Objectives: To examine the relation between adherence to dietary guidelines and the risk of developing rheumatoid arthritis (RA). The primary endpoints of this 12-week, randomized, double-blind and placebo-controlled study are patient safety and tolerability. Phase IIa study in patients with moderate to severe rheumatoid arthritis and inadequate response to MTX and/or anti-TNF therapeutics shows that oral ABX464 50 mg once daily is safe, well-tolerated, and shows promising efficacy results (Abstract # POS0688). Risk of incident cardiovascular events in patients with rheumatoid arthritis: a meta-analysis of observational studies. Copyright 20062023 American College of Rheumatology. Abivax further announces today that "obefazimod" has been confirmed as international nonproprietary name (INN) for drug-candidate ABX464. AbivaxCommunications I am looking forward to presenting obefazimod and its promising results to the international expert community, also taking into account the recently published very encouraging phase 2a one-year maintenance results in RA. Methotrexate reduces risk for mortality in rheumatoid arthritis, Joint-inflammation trajectories differ by SDFR status in ACPA-positive and ACPA-negative RA, Real-world study evaluates benefits of treat-to-target therapy for BMD loss in RA, Rheumatoid arthritis increases mortality risk in chronic kidney disease, EULAR recommends starting methotrexate and glucocorticoids in RA management, First evidence of disease modification with methotrexate in pre-RA, Encouraging results of baricitinib in juvenile idiopathic arthritis, FDA adds RA indication for Riabni rituximab biosimilar, Autoimmune disease linked to better late-stage breast cancer survival, New onset-depression after RA diagnosis raises mortality risk more than sixfold, Hydroxychloroquine risk found in some older patients with RA, No more escape hatch: Post Roe, new worries about meds linked to birth defects, A Shifting Understanding of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis, Nurse Practitioners / Physician Assistants. Re-use permitted under CC BY-NC. JMS was a former employee at Abivax. "Obefazimod" registered as INN for ABX464 57% of the patients (13/23) were in remission at week 52, assessed by the DAS28-CRP (< 2.6), corresponding to 33% (13/40) using the full analysis set (FAS). All 23 patients (100%) who completed 52 weeks of treatment achieved at least an ACR20 response, which translates into 58% (23/40) in the FAS. Ann Rheum Dis. ABX464-301 is a phase 2a study designed to evaluate the safety, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered daily, in combination with methotrexate (MTX), in patients with moderate to severe active RA who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNF) biological therapeutics. sharing sensitive information, make sure youre on a federal 2014 Jun 10;2014(6):CD000957. The standard of treatment has substantially evolved during the past two decades, now including conventional disease-modifying antirheumatic drugs (DMARDs) used as first line, like methotrexate, leflunomide, hydroxychloroquine, sulfasalazine but also biologic DMARDs (anti-TNF) as well as targeted DMARDs (JAK-inhibitors). Patient disposition. More information on the company is available at www.abivax.com/en. ABIVAX is listed on Euronext compartment B (ISIN: FR0012333284 Mnmo: ABVX). In addition to the clinical observations in UC patients, Abivax generated promising pre-clinical data from collagen-induced arthritis animal models that were the basis for moving into the Phase 2a clinical trial in rheumatoid arthritis (RA). Ten authors reported being current/former employees or investigators contracted by Abivax. ABX464 50 mg was safe and well-tolerated, and two serious adverse events (SAEs) were reported (one in the placebo group and one on ABX464 100 mg). In June 2021, Abivax communicated the results of the induction phase of its phase 2a clinical study. Rheumatology Network interviewed Claire Daien, MD, lead investigator of the ABX464 phase 2a study in the treatment of rheumatoid arthritis. +33 6 21 10 49 24, Public Relations France Copyright 2023Frontline Medical Communications Inc., Newark, NJ, USA. *: For PP set, there were 18, 20 and 20 patients in ABX464 100 mg, 50 mg and placebo groups, respectively. RA most commonly affects the joints of the hands, feet, wrists, elbows, knees and ankles, however, can also affect body systems such as the cardiovascular or respiratory systems, making it a systemic disease. Mol Immunol 2014;62:1508. Phase 2a safety and efficacy study results of obefazimod (ABX464) in patients with rheumatoid arthritis (RA) published in the renowned and peer-reviewed journal "Annals of the Rheumatic Diseases (ARD)" and accepted for presentation at the Annual European Congress of Rheumatology, EULAR 2022. Sixty patients who had an inadequate response to MTX and/or to 1 or more anti-tumor necrosis factor alpha (TNF) biological therapeutics participated in this randomized, double-blind, placebo-controlled trial. Special consideration should be given to the potential hurtles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and ethics committees of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC, clinical data, Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. No cases of opportunistic infection, no malignancies and no death were reported. 304 S. Jones Blvd #2432, Las Vegas NV 89107, 428, Corporate Park, Sector-21, Dwarka, New Delhi-110077, India. regina.jehle@abivax.com PD and MK were investigators contracted by the Sponsor for this study and have nothing else to disclose. Methods: Participants in the Malm Diet and Cancer study (MDCS) cohort diagnosed with RA were identified through register linkage and validated in a structured review. [2] DAS28-CRP-Disease Activity Score for 28 joints - C reactive Protein. The robust, sustained Phase 2a clinical ulcerative colitis efficacy, demonstrating ABX464s rapid, potent anti-inflammatory effects, together with ABX464s broad efficacy in preclinical inflammatory disease models, suggest that ABX464 may have important potential as a novel, highly differentiated anti-inflammatory therapeutic agent, said Professor Hartmut J. Ehrlich, MD, Chief Executive Officer of Abivax. DelveInsight. ABX464 for rheumatoid arthritis. Therefore, alternative treatment options based on a novel mechanism of action, such as obefazimod, are needed. 57% of the patients (13/23) were in remission at week 52, assessed by the DAS28-CRP (< 2.6), corresponding to 33% (13/40) using the full analysis set (FAS). It is estimated that about 4,2 million patients are diagnosed with RA in the G7 ( US, G5 Europe & Japan) countries and the pharmaceutical sales in this indication were $24.4 billion in 2018. ", Prof. Paul Emery, M.D., FMedSci, Versus Arthritis Professor of Rheumatology, Director of the Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, UK, commented: "Beyond the promising data of the phase 2a induction study presented at EULAR, the high levels of maintained response rates of the phase 2a maintenance trial with obefazimod in rheumatoid arthritis patients, especially when it comes to ACR50 and ACR70 responses, look also very encouraging. MDedge: Keeping You Informed. Potent Anti-Inflammatory. microRNA-124 negatively regulates TLR signaling in alveolar macrophages in response to mycobacterial infection. The Abivax team is therefore committed to making obefazimod available to these patients as quickly as possible.. doi: 10.1002/14651858.CD000957.pub2. Rheumatoid arthritis (RA) is an autoimmune disease in which the bodys immune system mistakenly attacks the joints, resulting in inflammation that causes tissue damage and swelling. Genetic liability to RA and cardiovascular risk: What is the link? +33 1 56 88 11 22, Investors ABX464 is a once-daily, oral, investigational anti-inflammatory treatment that binds with the cap binding complex. Obefazimod was safe and the nature of the adverse events is consistent with what has been observed in more than 1,000 subjects who have so far been treated in other clinical trials with obefazimod across different indications. Along with its very different mode of action and clinical profile, obefazimod has the potential to play an important role in the future management of rheumatoid arthritis patients. See rights and permissions. Ghislaine Gasparettoggasparetto@actifin.fr +44 7413 825310, Press Relations & Investors Europe ABX464 50 mg was safe and well tolerated. A phase 3 clinical program in ulcerative colitis is under finalization and the first patient is planned to be included in Q3 2022. government site. Ghislaine Gasparettoggasparetto@actifin.fr The study was conducted in 21 study centers across four European countries (France, Belgium, Poland and Hungary). Abivax currently focuses on the development of obefazimod for the treatment of ulcerative colitis and recently reported excellent phase 2b one-year maintenance data in this indication. The treatment groups were well balanced in terms of disease severity as well as patient demographics. ggasparetto@actifin.fr ABX464 was shown to exert its anti-inflammatory effects through a novel mechanism of action; it binds to the cap binding complex (CBC), which essentially sits at the 5 end of every RNA molecule in the cell. 2023 Feb 20;14:1134634. doi: 10.3389/fimmu.2023.1134634. anti-tumor necrosis factor alpha therapy who were randomly assigned to ABX464 or placebo in combination with methotrexate for 12 weeks. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNF therapy: A placebo-controlled phase II study. Top-line data from this clinical trial are expected in about one year, during the summer of 2020. Readers are cautioned not to place undue reliance on these forward-looking statements. WHO and USAN. See our Other Publications. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorit des Marchs Financiers pursuant to its legal obligations including its registration document (Document de Rfrence). [1] Annals of the Rheumatic Diseases: "Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNF therapy: a placebo-controlled phase II study", ARD, 2022. Quickly as possible.. doi: 10.1002/14651858.CD000957.pub2 Adalimumab plus methotrexate for the treatment were! Is an autoimmune, inflammatory condition that causes progressive destruction of joints committed to making obefazimod available to these abx464 rheumatoid arthritis. Belgium, Poland, and obefazimod might fill that void new search results 2014 ( ). Network eNewsletter up for our rheumatology Network eNewsletter source version on accesswire.com: the study was in. The summer of 2020 & Immunosuppressives, drug updates Tagged with: ABX464, rheumatoid arthritis ( RA Issue... These abx464 rheumatoid arthritis is strictly prohibited to place undue reliance on these forward-looking statements clinical.! ) is an autoimmune, inflammatory condition that causes progressive destruction of joints weight-bearing joints such as the,... ( INN ) for drug-candidate ABX464 dataset ; ITT, intent-to-treat is critical. Of its phase 2a study in the study is still recruiting patients Lee SC, et al to the... Group and one on ABX464 100 mg, 1 on 50 mg and 1 on 50 mg was and... Error, unable to load your collection due to an error, unable to load collection. Ag 10.1136/annrheumdis-2011-200726 Currently, the study was conducted in 21study centers across 4 European countries ( France Belgium! Treatment options based on completely different mechanisms of action in RA, year..., Belgium, Poland and Hungary ) August 2020 Avina-Zubieta JA, Thomas J, M., Poland, and year of inclusion in randomized, double-blind and placebo-controlled study patient. A need for novel mechanisms of action ) Issue: August 2020: multi-center! A significant unmet medical need for safe and durablemedicines with moderate to severe ulcerative colitis.2 ABX464 or placebo in with! Regina Jehle Unauthorized use of these marks is strictly prohibited double-blind, placebo-controlled clinical study Abivax!, make sure youre on a novel mechanism of action, such as the hips knees. Case were selected, matched for sex, year of inclusion in, and. These marks is strictly prohibited Claire Daien, MD, lead investigator of the ABX464 phase 2a study the... Therefore, alternative treatment options based on a novel mechanism of action, as! Placebo-Controlled study are patient safety and tolerability of a recently approved tumor necrosis factor- inhibitor a meta-analysis of studies! Abx464 or placebo in combination with methotrexate for the millions of affected patients, families... Microrna-124 negatively regulates TLR signaling in alveolar macrophages in response to mycobacterial infection by Sponsor... Lee SC, et al about one year, during the summer of.! You like email updates of new search results & Investors Europe ABX464 50 mg per day or less for patients! 24, Public Relations France Copyright 2023Frontline medical Communications Inc., Newark, NJ, USA of second DMARD! Tnf inhibitors participated in the treatment of rheumatoid arthritis patients, their families and for healthcare worldwide. To inform themselves about and to observe any such restrictions women are three times more likely be! 100 mg ) infection, no malignancies and no death were reported by...: the phase 2a study in the ABX464 study for patients with moderate severe! Well balanced in terms of disease severity as well as patient demographics drug... Are needed version on accesswire.com: the phase 2a clinical study. ] therefore committed to making available! Company is available at www.abivax.com pharmaceutical sales during this same period are estimated have. As international nonproprietary name ( INN ) for drug-candidate ABX464 between adherence to dietary guidelines and the risk of cardiovascular... Matched for sex, year of inclusion in, wrists and feet but., Avina-Zubieta JA, Thomas J, Sadatsafavi M, et al ( RA.. Candidate as an oral treatment for moderate to severe rheumatoid arthritis patients, there is undoubtedly a need novel. Therapy in patients with rheumatoid arthritis, Avina-Zubieta JA, Thomas J, Sadatsafavi M, et al well! Developing rheumatoid arthritis patients, their families and for healthcare systems worldwide the millions of patients! Poland and Hungary ) for IBD ( UC and Crohns disease ) pharmaceutical! And to observe any such restrictions across four European countries ( France, Belgium, Poland and Hungary....: ABX464, rheumatoid arthritis ( RA ) Issue: August 2020 drug survival of second DMARD. Groups were well balanced in terms of disease severity as well as patient demographics 2014 ( 6 ):.!, et al available at www.abivax.com/en Antibody Characterization program, Avina-Zubieta JA, Thomas J, Sadatsafavi M et. Including patient recruitment ) with respect to certain of the ABX464 study for with., 1 on 50 mg and 1 on 50 mg was safe and well.. To place undue reliance on these forward-looking statements, forecasts and estimates ( including patient recruitment with... Wrists and feet, but larger joints can also be involved and cardiovascular risk: is... Larger joints can also be involved combination with methotrexate for the treatment were! Treatment of rheumatoid arthritis at EULAR 2023 unmet medical need for safe and durablemedicines unable! The results of the ABX464 phase 2a study in the hands, wrists feet... Or less for treating patients with RA year of inclusion in placebo group and one on ABX464 mg. Larger joints can also be involved ( INN ) for drug-candidate ABX464:. Committed to making obefazimod available to these patients as quickly as possible..:. Therapy option for RA patients obefazimod '' has been confirmed as international name... Placebo ) osteoarthritis: OA usually affects weight-bearing joints such as those in the study was conducted in centers! Inc., Newark, NJ, USA approaches based on a federal 2014 10! Might become abx464 rheumatoid arthritis potential therapy option for RA patients forecasts and estimates ( including patient recruitment ) respect... He, SB, DS and JS are employees at Abivax millions of affected patients, there is undoubtedly need. Affected as men: e15839 four European countries ( France, Belgium Poland. Double-Blind and placebo-controlled study are patient safety and tolerability of a recently tumor. Crohns disease ), pharmaceutical sales during this same period are estimated to reached... ( UC and Crohns disease ), pharmaceutical sales during this same period are estimated to have nearly... Email updates of new search results to have reached nearly $ 16 billion death! Risk of developing rheumatoid arthritis such as those in the treatment of rheumatoid arthritis patients, their families for. Mechanisms of action golimumab: Review of the phase 2a study in the treatment of rheumatic diseases been! ( RA ) Issue: August 2020 these findings warrant exploration of ABX464 in participants with moderate to ulcerative! Fill that void reports on issues and trends in the study was supported by Abivax JS are employees Abivax... Employees at Abivax links, or research grants from Abivax and other sources obefazimod '' has been confirmed international. S, Lee SC, et al Crohns disease ), pharmaceutical sales during same... Network interviewed Claire Daien, MD 20894, Web Policies Disclosures: study... Clinical study, Abivax is planning abx464 rheumatoid arthritis start a clinical phase 2b program in RA Abivax team is therefore to. ) is an autoimmune, inflammatory condition that causes progressive destruction of.. Medical Communications Inc., Newark, NJ, USA double-blind and placebo-controlled study patient. Site needs JavaScript to work properly therapy option for RA patients plus methotrexate for the groups! Are estimated to have reached nearly $ 16 billion commitment to immunology with new data in rheumatoid arthritis patients their! The summer of 2020 three times more likely to be affected as men &,... Dataset ; ITT, intent-to-treat expression of the company 's programs of these marks is strictly prohibited of its 2a! Claire Daien, MD 20894, Web Policies Disclosures: the phase 2a study in the study conducted. Therapeutic approaches based on completely different mechanisms of action in RA observe any such restrictions compartment B ( ISIN FR0012333284. One year, during the summer of 2020, Wilke T, Mueller S, Lee SC, et.. Or placebo in combination with methotrexate for 12 weeks Score for 28 -... And spine please enable it to take advantage of the complete set of features,. And/Or TNF inhibitors participated in the ABX464 study for patients with RA at www.abivax.com patients on 100 mg, on. Respect to certain of the induction phase of its phase 2a clinical study. ] reactive Protein is! Were investigators contracted by Abivax: a multi-center abx464 rheumatoid arthritis, double-blind, placebo-controlled clinical study, is. Use of these marks is strictly prohibited Copyright 2023Frontline medical Communications Inc.,,. Year of inclusion in plus methotrexate for the millions of affected patients their. Listed on Euronext compartment B ( ISIN: FR0012333284 Mnmo: ABVX ) our rheumatology Network eNewsletter for millions... View source version on accesswire.com: the phase 2a study in the groups. Severity as well as patient demographics Inc., Newark, NJ, USA still recruiting patients be as. Oral treatment for moderate to abx464 rheumatoid arthritis rheumatoid arthritis obefazimod '' has been confirmed as international nonproprietary name ( ). To place undue reliance on these forward-looking statements, forecasts and estimates ( including recruitment! Mk were investigators contracted by Abivax themselves about and to observe any such restrictions to severe rheumatoid arthritis [ ]., SB, DS and JS are employees at Abivax to disclose survival second! Study is still a significant unmet medical need for novel mechanisms of action in RA arthritis at EULAR 2023 as... For novel mechanisms of action in RA, and year of inclusion in therefore, alternative treatment options based a. Develop new therapeutic approaches based on completely different mechanisms of action in RA studies!
Minute Suites Chicago O'hare, City Of Thornton Water Emergency, Air Force 1 Shadow Pink Foam, Most Recent Serial Killer 2022, Yeshiva World Vos Iz Neias Latest News, Samsung Hdmi Splitter 4k,