RHB-104 is an antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
Currently, RHB-104 is undergoing a first Phase III study for Crohn’s disease and a Phase IIa study for multiple sclerosis.
Once granted, patent application number 13/722,395, entitled ‘Methods and Compositions for Treating Inflammatory Bowel Disease’, is expected to be valid until October 2029.
Following approval, patent application number 14/271,758 entitled ‘Methods and Compositions Comprising Rifabutin, Clarithromycin, and Clofazamine’, is expected to be valid until at least February 2029.
RedHill Intellectual Property & Research director Danielle Abramson said: "Once issued, these two new US patents, carrying a patent term through at least 2029, will further enhance RedHill’s global patent portfolio covering RHB-104, a potential groundbreaking treatment for Crohn’s disease."
Currently, RHB-104 is undergoing a first Phase III trial to treat Crohn’s disease in the US and additional countries (the MAP US study).
Around 270 patients with moderately to severely active Crohn’s disease will be enrolled in this ongoing randomized, double-blind, placebo-controlled MAP US Phase III trial.
In the trial, patients are randomized 1:1 to receive either RHB-104 or a placebo for 52 weeks and evaluated for the primary endpoint of remission at week 26 of treatment.
The company intends to report interim analysis of the MAP US study in the second half of next year, after half of the patients expected to be enrolled in the study will have completed 26 weeks of treatment.
The company also intends to start a second Phase III trial with RHB-104 for Crohn’s disease (the MAP EU study) following the recent acceptance in the UK of its Clinical Trial Application (CTA).