FDA grants Fast-Track Designation to RHB-104 for nontuberculous mycobacteria infections

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation.

The granted QIDP designation allows RedHill to benefit from Fast-Track status, with an expedited development pathway for RHB-104 for the treatment of NTM infections, as well as Priority Review, which provides for a shorter review time by the FDA of a future potential marketing application. If approved for the treatment of NTM infections, RHB-104 would also receive an additional 5 years of US market exclusivity on top of the standard exclusivity period.

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.

In light of the QIDP designation, RedHill will consult with the FDA regarding its RHB-104 development program for NTM infections.

A first Phase III study with RHB-104 for the treatment of Crohn’s disease (the MAP US study) is currently ongoing in the US and additional countries. The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease, and potentially other autoimmune diseases, are related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.

Recently, RedHill also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (the CEASE MS study). Top-line final results from the CEASE MS study suggest meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development.