Redhill Biopharma Ltd (NASDAQ:RDHL) stock soared 28% following encouraging feedback from the U.S. Food and Drug Administration (FDA) on the approval pathway for its RHB-204 program targeting Crohn’s disease.
The FDA’s guidance permits Redhill to launch the first clinical trial focusing on a specific subgroup of Crohn’s patients infected with Mycobacterium avium subspecies paratuberculosis (MAP-positive). This innovative strategy aims to address both the underlying cause and symptoms of the disease, potentially making RHB-204 a breakthrough treatment if approved.
The upcoming Phase 2 trial will measure primary endpoints of mucosal and clinical remission linked to MAP infection status, as advised by the FDA. Leveraging advanced imaging and MAP detection techniques, the study’s design may allow for fewer participants, reducing costs and speeding up timelines.
RHB-204 is an improved next-generation version of the Phase 3-stage RHB-104, featuring 40% fewer pills to enhance patient adherence, safety, and tolerability. The drug is protected by patents through 2041.
This development builds on data from a 331-patient Phase 3 study where RHB-104 combined with standard care demonstrated a 64% improvement over standard care alone. The treatment also showed a favorable safety profile when used alongside anti-TNF therapies, immunomodulators, and steroids.
The global Crohn’s disease market is forecasted to grow from $13.6 billion to $19.1 billion by 2033, with a compound annual growth rate of 3.87%. Redhill is actively seeking non-dilutive funding sources through partnerships and grants to advance this program.
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