Abivax announces update to obefazimod Phase 2b clinical development program in moderately to severely active Crohn's disease

Obefazimod Crohn's Disease (CD) IND filed with the FDA in December 2023 and cleared to proceed.

In alignment with FDA feedback, Abivax to modify CD trial design and conduct dose ranging Phase 2b clinical trial

Start of patient enrollment planned for Q3 2024

12-week induction data read-out expected in 2H 2026

Abivax SA (Euronext Paris & 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 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 Q3 2024.

Sheldon Sloan, MD, M Bioethics, CMO of Abivax, says: 'The IND clearance by the FDA allows Abivax to move forward with the development of obefazimod for the treatment of Crohn's disease. The revised trial design incorporates FDA feedback, which we believe provides a more efficient pathway to a future NDA submission. We are excited to begin the obefazimod CD program, which has the potential to provide a meaningful benefit to patients in a therapeutic area with a high unmet medical need.'

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.

The corporate presentation on www.abivax.com has been updated to reflect these changes.

About Abivax

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 US, Abivax's lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @ABIVAX.

Contacts:

Abivax Communications

Regina Jehle

regina.jehle@abivax.com

+33 6 24 60 69 63

Abivax Investor Relations

Patrick Malloy

patrick.malloy@abivax.com

+1 847 987 4878