RedHill Biopharma receives approval of a European patent supporting RHB-104 for MS

Patent expected to be valid until 2032, once granted.

RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. A first Phase III study with RHB-104 for the treatment of Crohn’s disease is currently ongoing, as well as a Phase IIa proof-of-concept study for the treatment of MS.

“RHB-104 is a multifaceted drug that, in addition to bactericidal properties against intracellular infections, has potentially distinct mechanisms of action that include both anti-inflammation and neuroprotection. This new European patent is an important addition to RedHill’s already robust patent portfolio covering RHB-104 and we continue to pursue additional patent claims for this potentially groundbreaking therapy,” stated Danielle Abramson, RedHill’s Director of Intellectual Property & Research. “We are very pleased with the progress achieved with the RHB-104 development programs for Crohn’s disease and multiple sclerosis and look forward to several important upcoming potential milestones. Interim results from the Phase IIa proof-of-concept study with RHB-104 for relapsing-remitting multiple sclerosis were encouraging, demonstrating positive safety and efficacy signals and we are expecting top-line final results from this study during the fourth quarter of 2016. A DSMB analysis in the Phase III study with RHB-104 for Crohn’s disease is also expected in the fourth quarter.”

Patents covering the antibiotic combination therapy, including the RHB-104 formulation and uses, have been granted in over 25 countries, including the US, Australia, Canada, Japan and multiple European countries. This new allowed patent application further expands RedHill’s worldwide patent portfolio covering the use of RHB-104 for the treatment of multiple sclerosis and is expected to be valid until 2032, once granted. Additional US and foreign patent applications are pending, covering the use of RHB-104 for the treatment of multiple sclerosis, with recent patent allowances in a number of territories.

RHB-104 is being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS), with an open-label Phase IIa proof-of-concept clinical study currently ongoing in Israel (the CEASE-MS study). The Phase IIa CEASE-MS study was initiated following several successful pre-clinical studies conducted by RedHill and is designed to evaluate RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS. Patients enrolled in the study received 24 weeks of treatment with RHB-104 as an add-on therapy to interferon beta-1a and were then evaluated for an additional 24-week follow-up period during which they were treated with interferon beta-1a alone. Top-line interim results announced in March 2016, after completion of the 24-week treatment period, demonstrated positive safety and efficacy signals, including an encouraging relapse-free rate, Expanded Disability Status Scale (EDSS) scores and MRI results, which support further clinical development. Top-line final results from the CEASE-MS study are expected in the fourth quarter of 2016.

RHB-104 is also undergoing a first Phase III study for Crohn’s disease in the US, Canada, Israel, Australia and Europe (the MAP US study). With over 200 patients of the planned total of 270 enrolled to date in the ongoing randomized, double-blind, placebo-controlled MAP US study, interim data and safety monitoring board (DSMB) analysis is expected in the fourth quarter of 2016.

RedHill is currently reviewing a possible amendment to the Phase III MAP US study protocol intended to further enhance the overall robustness of the study, provide a more precise assessment of RHB-104’s treatment effect, collect additional endoscopic mucosal healing data, further evaluate the Crohn’s disease population enrolled and address retention and early terminations. The company expects to provide further details in the coming weeks, once plans are finalized.