Abivax has received the first Phase IIb clinical trial authorisation from Canada for ABX464 to treat ulcerative colitis (UC).
The company plans to conduct the clinical trial largely in Europe, as well as Canada.
The randomised, double-blind, placebo-controlled, dose-ranging Phase IIb trial is being conducted in 232 UC patients and will have three escalating doses of once-daily oral ABX464 (25 mg/day, 50 mg/day and 100 mg/day) and placebo.
Set to be conducted in up to 150 sites in more than 15 countries, the study includes a 16-week induction phase followed by an open-label maintenance study.
The trial’s primary endpoint is a reduction in modified Mayo Score at eight weeks, and secondary endpoints will include clinical remission, endoscopic improvement, and biomarker fecal calprotectin.
Abivax CEO Hartmut Ehrlich said: “We have received full clearance for the Phase IIb study in ulcerative colitis by the regulatory authorities and ethics committee in Canada, the first country to approve of those to which applications were submitted, and we expect the first patient to be enrolled during the second quarter of 2019.”
“In addition to the observed effects of ABX464’s unique mechanism of action, preclinical and clinical data also suggest a broadly applicable anti-inflammatory effect, which has prompted the preparation of Phase IIa clinical trials of ABX464 in Crohn’s disease and rheumatoid arthritis.”
The company has already submitted a Phase IIa clinical trial in rheumatoid arthritis to regulatory authorities in several countries for approval.
Top-level results from the study are expected around the end of next year.
Abivax expects to submit clinical trial applications for a Phase IIa study in Crohn’s disease in the coming weeks.
Last September, the company reported positive topline results from its Phase IIa ABX464-101 clinical trial that evaluated the safety and efficacy of ABX464 to treat UC.