ABIVAX (ABVX) investor relations material

Key data and study design

• Phase III program included two induction trials and one maintenance trial, enrolling 1,272 patients with no limit on prior treatment failures; nearly half had prior inadequate response to advanced therapies, including JAK inhibitors.

• Week 8 data focused on a severe, refractory ulcerative colitis population, with about 60% having the highest endoscopic severity score and 50% failing at least one advanced therapy.

• Both 25mg and 50mg doses showed significant clinical response and remission, with deltas of 13% and 16% over placebo, respectively.

• Dosing flexibility is emphasized, with higher doses favored for more severe or refractory patients.

• Both doses showed similar efficacy in patients without prior advanced therapy inadequate response.

Efficacy and safety insights

• 50mg obefazimod led to significant improvements in clinical, endoscopic, and histologic endpoints at 8 weeks, regardless of prior therapy failures.

• Clinical response rates remained robust even in patients with multiple prior therapy failures, including JAK inhibitor exposure.

• Safety profile was similar to placebo, with headache as the most common TEAE, more frequent at 50mg but rarely leading to discontinuation; other TEAEs included nausea and increased lipase.

• No new adverse events of concern; lipase elevations were minor and not clinically significant.

• Obefazimod was well tolerated, with no new safety signals identified for either dose.

Maintenance and long-term outcomes

• Over 50% of induction responders achieved remission at 48 weeks in Phase II; 40% of non-responders at 8 weeks reached remission at one year.

• Maintenance dosing may be tailored, with more severe patients likely needing to remain on higher doses.

• Durability and depth of remission are key for long-term treatment decisions.

• Upcoming maintenance and quality of life data are expected to further inform positioning.