Abivax Completes Enrollment in ABX464 Trial for Ulcerative Colitis

Abivax Completes Enrollment in ABX464 Trial for Ulcerative Colitis
Abivax has completed patient enrollment, ahead of schedule and despite the COVID 19 pandemic, in its Phase 2b trial evaluating ABX464 as a treatment candidate for people with moderate-to-severe ulcerative colitis (UC). Top-line results are expected by June 2021, the company announced. The trial, called ABX464-103 (NCT03760003), has enrolled a total of 232 adults with moderate-to-severe UC. It is being conducted across multiple clinical sites in 15 European countries, the U.S., and Canada. "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," Paul Gineste, Pharm D, vice president of clinical operations of Abivax, said in a press release. "I would particularly like to thank our very committed investigators, our CRO [contract research organization], 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," Gineste added. ABX464 is an oral small molecule that promotes the production of a microRNA, called miRNA-124, which has strong anti-inflammatory activity. MicroRNAs are tiny RNA molecules that regulate gene expression, or activity, within cells. They bind to a particular gene’s messenger RNA (mRNA) — the molecule generated from DNA and used as the template for protein production — to prevent the generation of that protein. The ongoing ABX464-103 trial is assessing the safety and effectiveness of three daily doses of ABX464 (25, 50, or 100 mg) versus a placebo in patients with moderate-to-severe UC. After comple
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