The decision follows a pre-planned review of safety data.
RHB-104 is an antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
It has been developed on the evidence backing the theory that Crohn’s Disease, and potentially other autoimmune diseases and Mycobacterium avium subspecies paratuberculosis (MAP) infection are related to each other in susceptible patients.
Another DSMB meeting, likely to be in the second quarter next year, will feature an interim efficacy analysis besides determining the option of an advanced stop for success to achieve overwhelming efficacy, as per a pre-decided statistical threshold.
The phase 3 study of RHB-104 will be a randomized, double-blind, placebo-controlled trial in patients having moderate to severely-active Chron’s disease.
About 242 patients have so far been enrolled out of 410 who will be participating in different locations in the US, Canada, Israel, Europe, Australia and New Zealand.
The patients will be randomized in the ratio of 1:1 to be subjected to either RBH-104 or a placebo. The primary endpoint will be disease remission which is a decrease in Crohn’s Disease Active Index (CDAI) to less than 150 during the 26th week.
The secondary and exploratory endpoints will feature state of response during week 26, maintenance of remission up to week 52 besides endoscopic evaluation of mucosal healing and efficacy outcome measures with respect to the presence of MAP bacterial infection.
RedHill Biopharma said that it would carry out additional studies before it files a New Drug Application (NDA) in the US for RHB-104.