Obefazimod

With an FDA filing already in for its oral IL-23 blocker in plaque psoriasis, Johnson & Johnson is turning its focus to inflammatory bowel disease, preparing a Phase III programme for icotrokinra after new data showed the pill produced dose-dependent benefits and a reassuring safety profile in patients with ulcerative colitis (UC).At the United European Gastroenterology (UEG) meeting this week, the company presented results from the Phase IIb ANTHEM-UC trial, which tested three once-daily oral doses of icotrokinra in 252 patients with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or Bristol Myers Squibb's S1P receptor modulator Zeposia (ozanimod) or approved JAK inhibitors.J&J said the study met its main goal, with 63.5% of patients on the highest 400-mg dose of icotrokinra achieving a clinical response after 12 weeks, versus 27% for placebo. Response rates were 58.1% and 54.7% for the 200-mg and 100-mg doses, respectively. Clinical response was defined as at least a 30% and two-point drop in the modified Mayo score, along with improvement in rectal bleeding or a rectal bleeding subscore of 0 or 1.Early symptom reliefAcross key secondary measures — including clinical remission, symptomatic remission and endoscopic improvement — all dose groups outperformed placebo. At the 12-week mark, 30.2% of patients on the 400-mg dose achieved clinical remission compared to 11.1% on placebo, while 46% reached symptomatic remission versus 19% for placebo. Improvements in symptomatic remission were already evident by the fourth week, J&J said. Meanwhile, endoscopic improvement was seen in 36.5% of patients in the high-dose arm, compared to a placebo rate of 14.3%.The frequency of adverse and serious adverse events was similar across all icotrokinra doses and placebo.Esi Lamousé-Smith, gastroenterology disease area lead at J&J, said in a release Tuesday that icotrokinra "marks the next chapter in our history of innovation in inflammatory bowel disease," building on the company's goal of translating IL-23 pathway biology into a targeted oral option. The drug is being co-developed with Protagonist Therapeutics.Move to Phase IIIBased on ANTHEM-UC, J&J is kicking off the Phase III ICONIC-UC trial as well as the Phase IIb/III ICONIC-CD study in Crohn's disease, both expected to begin enrolling later this month.Abivax's oral contender obefazimod may beat it to the market, however. The miR-124 enhancer also drew attention at UEG this week, showing a 29% placebo-adjusted difference in clinical response in patients who had failed up to four prior advanced therapies, according to a pooled analysis of Phase III studies.J&J's readout adds momentum to a broader programme for icotrokinra. The company recently reported favourable head-to-head psoriasis results versus BMS's TYK2 inhibitor Sotyktu (deucravacitinib) at the European Academy of Dermatology and Venereology (EADV) congress (see – Spotlight On: J&J's icotrokinra goes from promise to proof, cementing its case in psoriasis and Physician Views Results: Poll shows US dermatologists see icotrokinra as a differentiated oral option in psoriasis).

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.