RedHill Wins FDA Backing for First MAP-Targeted Crohn’s Trial

RedHill Biopharma said it has received written guidance from the U.S. Food and Drug Administration outlining a regulatory path for its investigational therapy RHB-204, clearing the company to launch a Phase 2 study in Crohn’s disease. The agency’s feedback followed a Type C meeting and will allow what RedHill calls the first clinical trial limited to patients infected with Mycobacterium avium subspecies paratuberculosis (MAP), a bacterium increasingly suspected of driving the inflammatory bowel condition. Under the FDA’s recommendations, the study will use mucosal remission—correlated with MAP status and clinical remission—as its primary endpoint. RHB-204 is an oral, fixed-dose combination of clarithromycin, rifabutin and clofazimine, designed as an optimized successor to RedHill’s RHB-104, which in a 331-patient Phase 3 trial improved efficacy by 64% over standard care. The new formulation cuts pill burden by 40% and is protected by U.S. patents until 2041. RedHill said it is pursuing non-dilutive financing, including grants, to fund the program and is exploring additional FDA designations such as breakthrough therapy status. The news sent RedHill shares up about 40% in pre-market Nasdaq trading on 21 July.