Today, Abivax announced landmark Phase 3 ABTECT maintenance trial results evaluating obefazimod in moderately to severely active ulcerative colitis. ☑️ At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p<0.0001) ☑️ Both 25 mg and 50 mg obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control ☑️ Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals ☑️ Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure ☑️ The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Q4 2026 ☑️ Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027 ☑️ Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results Read the full press release here: https://lnkd.in/eNPnenwK
About us
Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Abivax is currently evaluating its lead drug candidate, obefazimod, in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Abivax also plans to initiate a Phase 2a clinical trial of obefazimod in patients with Crohn’s disease. Obefazimod is an investigational, orally administered, once-daily therapy, which we believe has the potential to be a differentiated treatment option for inflammatory bowel diseases. It is the first and only molecule that enhances the expression of microRNA-124 (miR-124), a natural regulator of the inflammatory response. If approved, this therapy has the potential to establish a new therapeutic class currently being referred to as miR-124 enhancers.
- Website
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http://www.abivax.com
External link for Abivax
- Industry
- Biotechnology
- Company size
- 51-200 employees
- Headquarters
- Paris, Île-de-France
- Type
- Public Company
- Founded
- 2013
- Specialties
- R&D, Inflammatory Bowel Desease, Biotechnology, Innovation, Ulcerative colitis, and Crohn's disease
Locations
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Primary
Get directions
7-11, Boulevard Haussmann
Paris, Île-de-France 75009, FR
Employees at Abivax
Updates
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Abivax today reported its Q1 2026 financial results alongside additional three-year interim data, representing up to seven years of total treatment exposure, from Study 108, a Phase 2a/2b open-label extension trial of obefazimod: ☑️ Interim intent to treat (ITT) analysis from Study 108 supports strong durable clinical remission in patients treated with obefazimod. ☑️ Following two to four years of open-label treatment with 50 mg, 130 patients de-escalated to 25 mg, and at week 144, 68% (88/130) were in clinical remission and 80% (104/130) completed 144 weeks of treatment. ☑️ Patients in Study 108 were treated with obefazimod for up to seven years, with no new safety signals observed. ☑️ ABTECT Phase 3 maintenance trial results expected in late Q2 2026. ☑️ Strong financial position, providing operational runway into Q4 2027. We remain committed to our mission of developing transformative therapies for people living with chronic inflammatory diseases and look forward to the milestones ahead. Read the full press release: https://lnkd.in/eVtyQ3qb
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For millions of people living with #CrohnsDisease or #UlcerativeColitis, #InflamatoryBowelDiseases are not just a diagnosis, it's a daily reality. At Abivax, we are devoted to developing transformative therapies that harness the body's natural regulatory mechanisms, with the goal of alleviating the enduring impact that #IBD has on people’s lives. Today on #WorldIBDDay2026 and every day, we stand with the #IBD community. Learn more about our science here: https://lnkd.in/eBDceKXk
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As #DDW2026 comes to a close, we are proud to have participated in this year’s meeting and to have contributed to the ongoing scientific exchange in #InflammatoryBowelDisease, including #UlcerativeColitis. The conference provided a valuable opportunity to engage with the latest developments across the IBD landscape and to connect with the global gastroenterology community. Thank you to everyone who connected with the Abivax team at the conference. These interactions are essential as we continue working to advance innovative therapies for patients.
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Join us today at #DDW2026 for the Abivax industry‑sponsored symposium, “The Next Frontier in IBD: Late‑Stage Clinical Advances with Novel Therapeutic Pathways.” May 4, 2026 | 6:00–7:30 PM Dinner at 6:00 PM | Program begins at 6:30 PM Hyatt Regency McCormick Place, Level 2 – Regency CDE (Access via Sky Bridge, Grand Concourse Level 3) Presented by Bruce Sands, MD, MS; David Rubin, MD; and Parambir Dulai, MD, this symposium will explore late‑stage clinical advances and emerging therapeutic pathways in #InflammatoryBowelDisease (#IBD), including investigational approaches such as obefazimod. Stop by Booth #2215 to connect with the Abivax team and learn more about our research.
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We are here at #DDW2026 in Chicago! Our team is dedicated to advancing innovative therapies for people living with #InflammatoryBowelDisease and looks forward to engaging with the #IBD community to share scientific insights from our obefazimod program. Visit us at Booth #2215 to learn more about our work to improve outcomes for people affected by #IBD and view details on our nine presentations here: https://lnkd.in/eZmTKef9
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We look forward to presenting at #DDW2026, highlighting the potential of obefazimod for the treatment of #UlcerativeColitis in patients with #InflammatoryBowelDisease (#IBD). Our nine accepted abstracts reflect continued progress across the obefazimod clinical and preclinical programs, including comprehensive efficacy, safety, and patient‑reported outcomes from the Phase 3 ABTECT induction trials, as well as data from preclinical anti‑fibrotic models in IBD. These presentations showcase key clinical and translational insights into obefazimod’s activity and its potential to address both inflammation and fibrosis in IBD. We invite attendees to engage with our presentations and connect with members of the Abivax team at booth #2215 to discuss the data and its potential implications for patients living with #IBD. Learn more about the accepted abstracts in our press release: https://lnkd.in/eZmTKef9
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We are proud to share that Abivax has been honored in the “Avancée thérapeutique” category at the Grands Prix de la Santé by BFM Business, with our Chief Business Officer, Pierre C., accepting the award. This recognition underscores our dedication to advancing innovative therapeutic approaches for patients with significant unmet medical needs, including those living with #InflammatoryBowelDisease. We thank the organizers for this distinction and acknowledge the continued efforts of our teams and partners working to bring meaningful innovation to patients. To watch the ceremony, view the video starting at 10:45: https://bit.ly/4vEExQq
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Our CEO Marc de Garidel recently joined Daniel Levine on The Bio Report Podcast to discuss Abivax’s progress in #InflammatoryBowelDisease (#IBD) and the potential of obefazimod as a novel therapeutic approach for patients living with #CrohnsDisease and #UlcerativeColitis. The conversation highlights our commitment to advancing innovative treatments that may address significant unmet needs in IBD and improve long-term outcomes for patients. 🎧 Listen to the full interview here: https://bit.ly/4cwpbVb
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Abivax is pleased to announce the appointment of three experienced leaders who will help drive the Company’s next phase of growth. Michael Nesrallah, MBA, joins as Chief Commercial Officer and will lead global commercial strategy and launch preparation. He brings extensive leadership experience with deep expertise in gastroenterology and immunology. Keith Fournier, PhD RAC, joins as Senior Vice President, Global Regulatory Affairs, bringing deep expertise in global regulatory strategy and lifecycle management. Maurus de la Rosa, Dr., joins as Senior Vice President, Research, with extensive experience in immunology, and translational research. Together, their expertise across research, regulatory strategy and commercialization will play an important role in Abivax’s long-term success. Learn more about our growing team: https://lnkd.in/exQDbgva