RedHill Biopharma receives positive FDA feedback for RHB-204 in Crohn’s Disease

RedHill Biopharma (RDHL) received positive feedback from the FDA, following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the company’s potentially groundbreaking RHB-204 Crohn’s disease development program. The positive FDA feedback allows for the planned RHB-204 Phase 2 study to be the first ever clinical trial in Crohn’s disease to test a specifically defined population of Mycobacterium avium subspecies paratuberculosis infected – MAP-positive – CD patients. The company is collaborating with two academic centers for the provision of MAP detection diagnostics. The Phase 2 study is expected to have primary endpoints of mucosal remission – considered by FDA as a new gold standard in efficacy evaluation in Crohn’s disease -, correlated with MAP status and clinical remission. Patent protected until 2041, RHB-204 is a novel next-generation optimized formulation of Phase 3-stage RHB-104. Up to 40% of CD patients fail to respond to anti-TNF treatment. A safe and effective orally administered therapy would provide an alternative approach. The CD market is expected to expand significantly over the 2024-2033 forecast period, with sales in the U.S., Japan, and five major European markets, growing from $13.6B to $19.1B at a compound annual growth rate of 3.87%. Funding for this ground-breaking program is expected to be non-dilutive.