Abivax reports two-year efficacy and safety data of obefazimod phase 2b maintenance trial in ulcerative colitis

• The analysis demonstrates clinical remission in 52.5% (n=114) of 217 moderate to severe ulcerative colitis (UC) patients (intent-to-treat population, ITT) after two years (96 weeks) of once-daily oral 50mg obefazimod
• In the subgroup of patients who did not achieve a clinical remission after the 8-week induction study, 48.2% of the patients (n=81) achieved a de novo clinical remission after two years
• Endoscopic improvement and endoscopic remission at two years were achieved by 59.0% (n=128) and 35.9% (n=78) of the patients respectively
• The safety and tolerability profile observed was consistent with previous findings and no safety signals were observed

PARIS, France, April 17, 2023 -- 06:00 p.m. (CEST) -- Abivax SA (Euronext Paris: FR0012333284 -- ABVX), a Phase 3 clinical-stage biotechnology company focused on developing therapeutics that modulate the immune system to treat patients with chronic inflammatory diseases, today reports the results from the final analysis of its Phase 2b open-label maintenance study, including 164 patients who completed the second year of once-daily oral treatment with 50mg obefazimod. These data emphasize obefazimod's potential to maintain and further improve patient outcomes over time, as well as its safety and tolerability profile suitable for chronic use.

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: "These two-year maintenance results are a strong confirmation of obefazimod's potential to swiftly induce and, more importantly, maintain long-term efficacy in patients with moderate to severe ulcerative colitis.", and Sheldon Sloan, M.D., M. Bioethics, CMO of Abivax, added: "Patients suffering from chronic inflammatory diseases, such as UC, often struggle to find a long-term effective treatment. The existing high unmet medical need results from the significant proportion of UC patients who stop responding to currently available therapies within the first year of treatment, or who do not respond at all. Therefore, at Abivax, we want to make our drug-candidate obefazimod available as quickly as possible to patients suffering from ulcerative colitis and we believe that it has the potential to make a real difference to control the disease in the long run."

Prof. Bruce Sands, M.D., M.S., the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Health System, New York, NY, and principal investigator of the trials in the US, commented: "I am excited about the two-year efficacy results of the Phase 2b trial of obefazimod in patients suffering from moderate to severe UC. The rates of maintained efficacy observed at 96 weeks are excellent. Moreover, obefazimod also continues to show excellent safety and is well-tolerated by patients, which is important for its chronic, once-daily use. I am optimistic that the ongoing Phase 3 program with obefazimod in UC will confirm these very encouraging data. Patients, as well as gastroenterologists, are in need of a medication that is efficacious over a long period of time, safe and well-tolerated, and easy to administer at the same time."

(Dr. Bruce Sands is a paid consultant for Abivax and a member of the Steering Committee for the Phase 3 program. He has not been compensated for any media work.)

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