DGAP-News

Abivax completes recruitment of ABX464 Phase 2b induction study in ulcerative colitis

DGAP-News: ABIVAX / Key word(s): Study Abivax completes recruitment of ABX464 Phase 2b induction study in ulcerative colitis 30.11.2020 / 19:00 The issuer is solely responsible for the content of this announcement. Abivax completes recruitment of ABX464 Phase 2b induction study in ulcerative colitis

• Recruitment of 232 patients completed ahead of schedule with minimal impact by the Covid-19 pandemic
• Top-line results expected to be available in Q2 2021
• Maintenance open label extension Phase 2b study in UC progressing well with 130 patients enrolled and expanded for a second year
• Preparation for pivotal Phase 2b/3 Crohn's disease and Phase 3 ulcerative colitis studies ongoing

PARIS, November 30, 2020 - 7:00 p.m. (CET) - Abivax (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announced today the completion of recruitment for its Phase 2b induction study for the lead candidate ABX464 for the treatment of patients with moderate-to-severe ulcerative colitis. This study exceeded industry standard recruitment rates for UC, during the Covid-19 crisis, by utilizing the experience, relationships and data built by working across many UC studies with sites, in tandem with innovative recruitment solutions. The randomization of the targeted 232 patients has been completed ahead of schedule, with minimal impact of the Covid-19 pandemic on the pace of recruitment. Top-line results of the Phase 2b UC induction study, conducted in 15 European countries, Canada and the US, are expected to be available in Q2 2021.

"The completion of recruitment of the Phase 2b induction study in ulcerative colitis with ABX464, our lead clinical program, is a critical milestone for Abivax. We are very pleased that patients enrolled so rapidly into the trial, despite the Covid-19 pandemic.", said Paul Gineste, Pharm D., VP Clinical Operations of Abivax, and he continued: "I would particularly like to thank our very committed investigators, our CRO, IQVIA, and our clinical team who made this possible, despite challenging circumstances. We are now looking forward to the high-level data that we expect will become available in Q2 2021."