Abivax has completed dosing patients in the ABX464-101 trial, a Phase lla clinical trial investigating the safety and efficacy of ABX464 to treat patients with ulcerative colitis (UC).
The randomised, double-blind, placebo-controlled, proof-of-concept trial has enrolled 32 patients with moderate-to-severe active UC who have failed or are intolerant to immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids.
The patients have been randomised in 2:1 ratio to receive a once-daily dose of ABX464 at 50mg or placebo for two months.
They will undergo a one-month follow-up period to allow the investigators to collect and analyse data.
The trial is currently being conducted in 17 centres in seven European countries, including Belgium, France, Germany, Austria, Hungary, Poland and the Czech Republic, with plans to provide top-line results by September this year.
Abivax CEO Dr Hartmut Ehrlich said: “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.
“We’re on track to report top-line results from this trial in September of 2018 and, if positive, move ABX464 rapidly into a Phase llb clinical trial.”
ABX464-102 is a 12-month open-label follow-up study that will include patients who complete the ABX464-101 study.
ABX464-101 trial principal investigator Dr Severine Vermeire 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 enrol into the one year open-label extension study with ABX464 and ABX464-102, which will provide us with important long-term safety and maintenance efficacy data.”