Abivax(US:ABVX)2025-10-06 13:00Efficacy of Obefazimod in Ulcerative Colitis - In pooled ABTECT 1 & 2 trials, Obefazimod 50mg demonstrated a statistically significant clinical remission rate, with a 16.4% difference compared to placebo (p<0.0001)[19] - Obefazimod 25mg also showed a statistically significant clinical remission rate, with a 13.2% difference compared to placebo (p<0.0001)[19] - The 50mg dose achieved clinically meaningful improvements in all clinical endpoints, regardless of prior advanced therapy inadequate response (AT-IR)[23] - In patients with prior AT-IR, Obefazimod 50mg showed a 31% improvement in clinical remission compared to placebo (p<0.0001)[24] - In patients without prior AT-IR, Obefazimod 50mg showed a 26% improvement in clinical remission compared to placebo (p<0.0001)[24] - The 50mg dose also achieved clinically meaningful improvements in endoscopic and histologic endpoints regardless of prior AT-IR[27] - Clinical response with the 50mg dose was consistent across subgroups, including those with no prior AT-IR through 4+ AT-IR or JAK-IR[31] Safety Profile of Obefazimod - In the pooled ABTECT 1 & 2 full dataset, the most common treatment-emergent adverse event (TEAE) was headache, with an incidence of 24.1% in the Obefazimod 50mg group[36] - The rate of TEAEs leading to study drug discontinuation was 5.0% in the Obefazimod 50mg group[35] - Serious TEAEs occurred in 3.1% of patients in the Obefazimod 50mg group[35]