RedHill Biopharma Ltd., an Israeli biopharmaceutical company, announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering RHB-104.

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties, currently undergoing a first phase III study for Crohn’s disease and a phase IIa study for multiple sclerosis.

The patent application, entitled “Compositions Comprising Rifabutin, Clarithromycin, and Clofazamine and Uses Therof” significantly expands RedHill’s patent portfolio covering RHB-104 and is expected to be valid until 2029 once granted. Upon issuance, RedHill will hold five US patents and multiple international patents for RHB-104.

Danielle Abramson, Ph.D., RedHill’s Director of Intellectual Property & Research said, “We are very pleased to announce this new addition to RedHill’s already robust patent portfolio covering RHB-104. The phase III study with RHB-104 for Crohn’s disease, currently ongoing in the US and additional countries, is advancing well, with interim analysis expected in the second half of 2016.”

RHB-104 is currently undergoing a first phase III study for Crohn’s disease in the US, Canada, Israel, Australia and additional countries (the MAP US study). A second phase III study (the MAP EU study) is planned to be conducted in select European countries in parallel with the ongoing MAP US study. Interim analysis of the ongoing randomized, double-blind, placebo-controlled MAP US study is expected in the second half of 2016, after half of the 270 patients planned to be enrolled in the study will have completed 26 weeks of treatment.

RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS). The open label phase IIa, proof-of-concept clinical study is evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS (the CEASE-MS study). Top-line interim results are expected in the coming weeks.

Currently in a first phase III study for the treatment of Crohn’s disease (the MAP US study) and a second phase III study which is being prepared (the MAP EU study), RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. Interim analysis of the MAP US phase III study is expected in the second half of 2016.  RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical trials conducted with earlier formulations of RHB-104 include an Australian phase III study conducted by Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the phase III MAP US study. RHB-104 is covered by several issued and pending patents. RedHill is also conducting 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 (RRMS), with top-line interim results expected in the first quarter of 2016.