Obefazimod

50 mg once-daily dose of obefazimod led to a pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8; met primary and all key secondary endpoints in both ABTECT 1 and ABTECT 2 ABTECT trials enrolled refractory patient population with 47% of participants having prior inadequate response to advanced therapy, among whom 21% had prior inadequate response to JAK inhibitor therapy Obefazimod treatment was well tolerated with no new safety signals identified for both the 25mg and 50mg doses Abivax to present a second late-breaking abstract on October 6. Management to host a conference call to discuss results of both late-breaking abstracts at 9am ET / 3pm CET on October 6. October 05, 2025 – 5:00 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), 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, today announced results from the first of two late-breaking presentations at the United European Gastroenterology (UEG) Meeting in Berlin, Germany. The presentation includes results from Abivax’s Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod for the treatment of moderate-to-severely active ulcerative colitis, including previously reported findings and additional safety data at week 8. “There is an urgent need for new therapies to treat ulcerative colitis that deliver durable efficacy, safety, and the simplicity of oral, once-daily dosing,” said Bruce Sands, MD*, Professor of Medicine, Icahn School of Medicine at Mount Sinai. "The ABTECT Trials enrolled individuals with advanced disease, including many who had failed multiple lines of advanced therapy and a significant percentage of patients with prior JAK inhibitor failure. The refractory nature of this population underscores the significance of the results presented today.” A total of 1272 patients were enrolled across the ABTECT 1 & 2 trials. In the pooled full data set across ABTECT 1 & 2, no signal for serious, severe, or opportunistic infections or malignancies was observed. The most commonly reported TEAEs were headache (6%-placebo, 16%-25mg, 24.1%-50mg) with Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimen for both trials. Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p Abivax management will host an investor and analyst conference call tomorrow on October 6, 2025, at 9:00 a.m. ET / 3:00 p.m. CET to discuss the topline results. To participate, please use the following dial-in or webcast link: 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. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. The content above comes from the network. if any infringement, please contact us to modify.

Abivax fleshed out its big Phase 3 ulcerative colitis victory, presenting new analyses over the weekend of a past readout that sent its stock soaring. It assessed a pooled group of nearly 1,300 patients from two Phase 3 studies, looking at subsets of patients who failed prior treatment with biologics, JAK inhibitors and S1P modulators and those who did not. Among the patients who saw continued success with prior treatment, Abivax said obefazimod improved outcomes by 28% compared to placebo at the 50 mg dose. The result was highly statistically significant, with a p-value of p<0.0001. In patients who failed their prior therapies, obefazimod improved outcomes by 29% compared to placebo. The outcome was also statistically significant, but at a much more modest rate. The p-value was p=0.0242. Abivax defined failing previous treatment as “inadequate response, loss of response, or intolerance” to therapies like biologics, JAK inhibitors and S1P modulators,” according to a press release . Pfizer’s Xeljanz and AbbVie’s Rinvoq are the only JAK inhibitors approved for UC, while Bristol Myers Squibb’s Zeposia and Pfizer’s Velsipity are the only S1P modulators approved for the disease. Other biologics include TNF blockers like AbbVie’s Humira and α4β7 integrin antagonists such as Takeda’s Entyvio. Obefazimod works differently from these medicines. The drug is designed to boost the expression of a specific microRNA called microRNA-124, which Abivax says can put the brakes on a runaway immune response. It’s a different approach than some of the other I&I success stories in recent years. Both Prometheus and Roivant turned mid-stage victories for their drugs targeting TL1A into multibillion-dollar deals. Prometheus was acquired by Merck for $10.8 billion in 2023, while Roivant sold the rights to its program to Roche for $7.1 billion the same year. The French biotech outlined the two Phase 3 wins in July, saying both studies succeeded and surpassed the results seen in earlier mid-stage studies. At the time, the news sent Abivax shares soaring, with the stock going from $10.00 to $68.60 in a single day. Its stock price $ABVX rose about 5% on Monday morning. Abivax’s current plan is to file for FDA approval once it has data from a 44-week maintenance trial that are expected in the second quarter of 2026.