Research & Development
Abivax modifies obefazimod Phase 2b programme for Crohn's Disease
2 February 2024 -

Clinical-stage biotechnology company Abivax SA (Euronext Paris:ABVX) (Nasdaq:ABVX) said on Friday that it will make changes to its Phase 2 development programme for obefazimod in Crohn's Disease (CD) after feedback from the US Food and Drug Administration (FDA).

Abivax will modify the trial design taking into account FDA recommendations and conduct a dose ranging Phase 2b clinical trial.

Patient enrolment is expected to start in the third quarter of 2024.

The Phase 2b trial will be double-blind and placebo-controlled, evaluating three obefazimod doses over a 12-week induction period followed by a 40-week maintenance period.

These adjustments are based on initial Phase 2a IND submission feedback. Abivax does not expect the changes to impact the overall programme budget and projected supplemental New Drug Application (sNDA) submission timeline.