RedHill Biopharma Ltd.
(NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has received from the Japan Patent Office a Notice of Allowance for a new patent covering RHB-104
for the treatment of multiple sclerosis (MS)
, which is expected to be valid until 2032, once granted. This notice follows RedHill’s recent announcement that the counterpart European patent application was approved by the European Patent Office.
RHB-104 is a proprietary, orally-administered, potentially groundbreaking 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. RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS), with top-line final results from a Phase IIa proof-of-concept study expected in the coming weeks (the CEASE-MS study).
The Phase IIa CEASE-MS open-label study was initiated following several successful pre-clinical studies conducted by RedHill and was 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.
RedHill’s robust RHB-104 patent portfolio, covering its oral antibiotic combination therapy, includes more than 26 patents in many countries, including the U.S., Australia, Canada, Japan and multiple European countries with additional patent claims being pursued.
A first Phase III study with RHB-104 for the treatment of Crohn’s disease is currently ongoing (the MAP US study). The randomized, double-blind, placebo-controlled MAP US study is planned to enroll a total of 410 subjects in up to 150 clinical sites in the U.S., Canada, Europe, Australia, New Zealand and Israel. A safety-focused independent data and safety monitoring board (DSMB) meeting is on track to take place in the fourth quarter of 2016. A second independent DSMB meeting is expected in the second quarter of 2017, after the first 205 patients complete 26 weeks of study participation. Patient 205 was randomized in August 2016.
The second DSMB meeting in the MAP US study will include safety and interim efficacy analysis and could potentially provide the opportunity to expedite the data locking process for the final analysis, once the study is complete. Importantly, this independent DSMB meeting will evaluate the option of an early stop for success, according to a pre-specified statistical significance threshold for analysis requiring overwhelming efficacy of RHB-104 versus placebo in the primary endpoint.
RedHill recently announced several improvements and enhancements to the Phase III Crohn’s disease program to provide a more comprehensive assessment of RHB-104’s treatment effect and bolster the likelihood of the study’s success even further. No changes are planned to the MAP US Phase III study’s primary endpoint or 90% power. Assuming enrollment of all 410 planned subjects, completion of patient recruitment is expected by the end of 2017.