Release Details

• Top-line results expected in September 2018

PARIS, July 19, 2018, 8:00 a.m. CEST – ABIVAX (Euronext Paris: FR0012333284 – ABVX), a biotechnology company harnessing the immune system to develop a functional cure for HIV, as well as treatments for inflammatory/autoimmune diseases and cancer, today announced the completion of dosing in its Phase 2a clinical trial ABX464-101 in 32 patients with moderate-to-severe ulcerative colitis (UC). Patients will be monitored and data collected and analyzed by investigators according to trial protocol. Top-line results are expected in September of 2018.

“Because of its mechanism, which has demonstrated powerful anti-inflammatory properties, ABX464 may have the potential to bring significant clinical benefit to patients struggling with inflammatory bowel diseases like UC so we are eager to see the top-line data from this study and continue development,” said Prof. Dr. Hartmut Ehrlich, M.D., Chief Executive Officer at ABIVAX. “We’re on track to report top-line results from this trial inSeptember of 2018 and, if positive, move ABX464 rapidly into a Phase 2b clinical trial.”

ABX464-101 is a randomized, double-blind, placebo-controlled Phase 2a proof-of-concept study evaluating the safety and efficacy of ABX464 50mg given once daily versus placebo for two months in subjects with moderate-to-severe active ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids. This clinical study is being conducted in 17 centers in seven European countries: Belgium, France, Germany, Austria, Hungary, Poland and Czech Republic. As of today, all of the 32 recruited patients, randomized 2:1 to receive ABX464 or placebo, have completed the study and will undergo a one-month follow-up period. The study employs state-of-the art technologies for monitoring potential treatment effects, including numerical recording of the colonoscopies with centralized reading.

Prof. Dr. Severine Vermeire, M.D., Head of the IBD center at the University Hospitals Leuven, Belgium and Principal Investigator of the study, said: “Even with the introduction of biologic treatments in recent years, there is still a largely unmet need as too many patients never respond or stop responding to biologics. It is encouraging that the majority of patients in the trial (21/32) agreed to enroll into the one year open-label extension study with ABX464, ABX464-102, which will provide us with important long-term safety and maintenance efficacy data.”

ABX464-102 is a 12-month open-label follow-up study for patients who complete ABX464-101.