ABIVAX (ABVX) The United European Gastroenterology (UEG) Congress UEG Week 2025 summary

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.

• Patient population was highly refractory, with about 60% having the most severe endoscopic scores, 50% exposed to at least one advanced therapy, and 21% having failed a JAK inhibitor.

• This was the first registration trial to include a significant number of JAK inhibitor-refractory patients.

• The webcast featured opening remarks from senior leadership and a clinical overview by Dr. Marla Dubinsky, with a review of new clinical data and a Q&A session.

Efficacy and clinical outcomes

• Both 25mg and 50mg doses showed significant efficacy, with 50mg achieving greater improvements in clinical, endoscopic, and histologic endpoints, including an 18% delta for endoscopic improvement.

• Efficacy was observed across naive and refractory patients, including those with multiple prior advanced therapy failures and JAK inhibitor exposure.

• Clinical response rates were robust, and the drug performed better than S1Ps in refractory populations.

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

Safety and tolerability

• Safety profile was similar to placebo, with the main difference being a higher rate of headaches at 50mg, typically resolving by day 2.

• Treatment-emergent adverse events were higher in the 50mg group (60.2%) compared to placebo (50.8%), but serious TEAEs and discontinuations were low and similar across groups.

• Headache was the most common TEAE, rarely leading to discontinuation; other notable TEAEs included nausea and increased lipase, with no new safety signals identified.

• Lipase elevations were minor, not associated with clinical pancreatitis or symptoms.