Abivax SA (ABVX) has reported pivotal Phase 3 ABTECT Maintenance trial, evaluating Obefazimod in adults with moderately to severely active ulcerative colitis.
Ulcerative colitis is a chronic inflammatory bowel disease that causes abdominal pain, diarrhea, and rectal bleeding, often disrupting quality of life. Current therapies can be limited by incomplete response or long-term safety concerns.
The ABTECT maintenance study was a randomized, double-blind, placebo-controlled trial enrolling 580 patients to assess Obefazimod's ability to sustain remission in those who has previously responded in the induction phase. At Week 44, both the 25 mg and 50 mg once-daily doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ?39.3% and ?40.3%, (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p<0.0001).
All secondary endpoints were met, showing robust efficacy across multiple measures of disease control, including endoscopic improvements and sustained symptom relief. Safety data were consistent with prior studies, with no new safety signals reported.Marc de Garidel, CEO of Abivax, stated: "Today's landmark Phase 3 results highlight the exceptional potential of obefazimod to redefine the treatment landscape for ulcerative colitis. With its compelling durable efficacy and favorable safety profile, combined with the convenience of a once-daily oral treatment, obefazimod has the potential to transform UC patient care."
David T.Rubin, M.D., University of Chicago Medicine, added: "The 44-week maintenance data demonstrate obefazimod's potential to deliver meaningful efficacy and durable disease control in ulcerative colitis. The novel mechanism, sustained clinical remission, and favorable long-term safety profile highlight its potential to address a significant unmet need in UC."
Abivax also highlighted 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 intends to submit an NDA to the FDA in late Q4 2026 for Obefazimod in UC. The company also expects topline results from its Phase 2b induction trial in Crohn's disease in mid-year 2027.
Half-year financial results are scheduled for September 21, 2026, providing investors with updated cash runway and pipeline guidance.
The company emphasized that Obefazimod, an oral small-molecule drug targeting miR-124 to modulate inflammation, could represent a differentiated approach in ulcerative colitis treatment.
ABVX has traded between $5.69 and $148.83 over the past year. The stock closed Monday's trading at $129.69, down 2.22%. During Overnight trading the stock is at $93.03, down 28.27%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.