Abivax announces patient-reported outcomes from ABTECT trial

Abivax (ABVX) announced patient-reported outcomes from its Phase 3 ABTECT 8-week induction trials evaluating obefazimod in adult patients with moderate-to-severely active ulcerative colitis. In addition to the trials’ clinical efficacy endpoints, PRO instruments are important in determining how patients perceived changes in their symptoms, quality of life, and activities of daily living. Improvements across all patient reported outcomes were observed from baseline to Week 8 in all PRO instruments utilized in the ABTECT induction trials evaluating bowel urgency, sleep interruption, fatigue, quality of life, and work productivity for both 50mg and 25mg once-daily obefazimod. At week 8 in the ABTECT 1 & 2 trials, 37% of patients taking once daily 50mg obefazimod reported no bowel urgency compared to 18.1% of patients in the placebo group, with improvements in BU observed as early as week two. Overall, 47.6% of patients on 50mg obefazimod reported no nocturnal bowel movements at week 8 compared to 24.7% in the placebo group. In the 50 mg group 17.1% of patients reported fatigue remission as measured with the Fatigue Numerical Rating Scale at week 8, compared to 7.7% in the placebo group. Detailed data across PROs, including data for both 25mg and 50mg groups, to be submitted for presentation at upcoming medical meetings