Abivax SA announced modifications to its Phase 2 development program of obefazimod in CD, to align with recent FDA feedback. The start of patient enrollment is expected in Third Quarter 2024. The obefazimod Phase 2b clinical trial in moderately to severely active CD is a double-blind placebo-controlled trial, evaluating three obefazimod doses.

The trial design consists of a 12-week induction period and a subsequent 40-week maintenance period. The revised trial design takes into account FDA recommendations provided in the frame of an initial Phase 2a IND submission. These adjustments to the obefazimod CD clinical program are not expected to have an impact on the overall program budget and projected supplemental New Drug Application (sNDA) submission timeline.