The QIDP status provides for accelerated review of the New Drug Application (NDA) as well as a five-year period of market exclusivity for the indication, if approved.
Currently, the drug is undergoing a first phase III clinical trial for the treatment of Crohn’s disease in the US and other countries.
RHB-104 is an antibiotic combination therapy formulated in an oral capsule. It is claimed to have intracellular, anti-mycobacterial and anti-inflammatory characteristics.
RedHill stated that RHB-104 is being developed on the growing evidence that backs the theory that Crohn’s disease as well as other possible autoimmune diseases is related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.
The Israeli pharma had recently finished a phase IIa clinical study to evaluate proof of concept of RHB-104 as an additional therapy to interferon beta-1a in patients undergoing treatment for relapsing remitting multiple sclerosis.
Dubbed as the CEASE MS study, the trial demonstrated sufficient positive safety and clinical signals after 24 weeks into the treatment with an add-on therapy in the form of RHB-104. The company decided to extend its clinical development following the top-line final results from the study.
The company intends to consult with the FDA on a development plan for NTM.