Biotechnology company Abivax has enrolled its first patient in a phase 3 trial of Obefazimod, a treatment for severe ulcerative colitis, according to an Oct. 11 press release sent to Becker's.
The trial will consist of 1,200 ulcerative colitis patients across 36 countries and 600 research centers to study 25mg and 50mg doses Obefazimod.
The trial will consist of two induction studies and one maintenance study in a double-blind, placebo controlled experiment that will include regulation from the FDA.
"As the principal investigator in the U.S., I am excited about the first patient included in the Obefazimod phase 3 program for the treatment of moderate to severe ulcerative colitis. Obefazimod has already shown very promising results in the precedent phase 2a and phase 2b induction and maintenance trials," Bruce Sands, MD, professor of medicine at the New York City-based Icahn School of Medicine at Mount Sinai, said in the release. "As a practicing gastroenterologist, I am confronted every day with the high unmet medical need for safe therapies that have long-term efficacy and convenient administration for patients with ulcerative colitis."