RedHill Biopharma Shares up 75% After Securing FDA Backing for Novel Crohn’s Disease Therapy RHB-204
RedHill Biopharma (RDHL) has received positive guidance from the U.S. Food and Drug Administration on its planned clinical pathway for RHB-204, a next-generation oral therapy aimed at a specific subset of Crohn’s disease patients. The FDA’s feedback paves the way for RedHill to launch the first-ever clinical trial focused exclusively on patients infected with Mycobacterium avium subspecies paratuberculosis (MAP), a bacterium long suspected to contribute to the disease.
Crohn’s disease is a chronic inflammatory condition affecting the digestive tract. Many currently available treatments are administered intravenously and can carry significant side effects. RedHill’s investigational drug RHB-204 is designed to be taken orally and is formulated to be more tolerable and easier to adhere to, offering a potential new alternative for patients who don’t respond to existing therapies.
The new trial, a Phase 2 study, will use advanced diagnostic tools to identify MAP-positive patients, enabling a more targeted approach. RedHill is working with leading academic centers to implement rapid MAP detection, addressing a major hurdle that has slowed progress in this area of research. The FDA has endorsed key trial endpoints that align with what is now considered the gold standard in measuring efficacy for Crohn’s disease therapies: mucosal healing paired with clinical remission.
RHB-204 is protected by patents through 2041 and is a refined formulation of RedHill’s earlier candidate, RHB-104. That predecessor showed a 64% improvement in treatment effectiveness compared to standard care in a Phase 3 study. RedHill believes that RHB-204’s reduced pill burden and improved safety profile could make it a strong candidate as either a standalone treatment or in combination with other medications.
The company is seeking non-dilutive funding to support the trial and has already submitted grant applications and opened discussions with external partners. It also plans to pursue regulatory designations that could accelerate the approval process and extend exclusivity, including orphan drug and fast-track status.
