Israel-based biopharmaceutical company RedHill Biopharma Ltd. recently announced its acquisition of two notices of allowance from the United States Patent and Trademark Office (USPTO) covering patient application numbers 13/722,395 and 14/271,758 for RHB-104, a novel antibiotic combination treatment in oral capsule form. The drug boasts an improved formulation that features enhanced intracellular, anti-mycobacterial and anti-inflammatory properties. At present, it is undergoing its first Phase III study as a potential treatment for Crohn’s disease, and a Phase IIa study for multiple sclerosis.
RedHill is expecting patent application number 13/722,395, titled, “Methods and Compositions for Treating Inflammatory Bowel Disease,” to be valid until October 2029, and patent application number 14/271,758 titled “Methods and Compositions Comprising Rifabutin, Clarithromycin, and Clofazamine,” to be valid until at least February 2029.
The company’s Director of Intellectual Property & Research, Danielle Abramson, PhD, said: “Once issued, these two new U.S. 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.”
The drug’s ongoing pioneering Phase III study testing RHB-104 as a possible novel treatment for Crohn’s disease is a randomized, double-blind, placebo-controlled MAP US Phase III study that aims to enlist the participation of 270 patients with a moderately to severely active form of the disease. The test subjects are randomized 1:1 to be given either the drug or a placebo for a length of 52 weeks. Upon the 26th week of treatment, they are then evaluated according to the study’s primary endpoint of remission. RedHill is expecting an interim analysis of the MAP US study within the latter half of 2016, once 50 percent of the total of enrolled patients have been treated for 26 weeks.
After the drug’s recent acceptance in the UK of its Clinical Trial Application, the company also reported its plans to begin a second Phase III study, indicated for Crohn’s disease. This MAP EU study is expected to begin in a number of European territories. Once it is launched, RedHill plans to conduct it along with the already ongoing MAP US Phase III study. The MAP EU study will be randomized, double-blind, and placebo-controlled and is aiming to enroll 360 patients diagnosed with moderately active Crohn’s disease. The test subjects will be randomized 2:1 and may receive either the drug or a placebo for a span of 52 weeks. Similar to the MAP US study, the patients will be assessed for remission after week-26 of treatment.
RHB-104 is also being considered as a potential treatment for the relapsing-remitting form of multiple sclerosis (RRMS). In this leg of the drug’s evaluation, RedHill reports the last patient has successfully been enrolled in an open label Phase IIa, proof of concept clinical trial. This study’s interim findings are expected between the fourth quarter of 2015 and the first quarter of 2016.