The European Patent Office has released a Notice of Intention to Grant a new patent to support RHB-104 as a therapy for relapsing-remitting multiple sclerosis (RRMS). RHB-104 is being developed by RedHill Biopharma.
Patents covering the use of RHB-104 exist in over 25 countries, including the U.S., Australia, Canada, Japan, and in various European coutries. Once granted, the new patent will be active in 38 European states until 2032.
“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,” Danielle Abramson, PhD, director of Intellectual Property & Research at RedHill, said in a company press release. “This new European patent is an important addition to RedHill’s already robust patent portfolio covering … this potentially groundbreaking therapy.”
RHB-104 is an oral antibiotic combination therapy with anti-mycobacterial and anti-inflammatory properties. It is under evaluation in a Phase 2a ‘proof-of-concept’ study for the treatment of RRMS in Israel (CEASE-MS study) that is now drawing to a close. In this trial, patients were administered RHB-104 in combination with interferon beta-1a (which has been shown to slow the progression of MS) for 24 weeks, and evaluated for an additional 24-week follow-up period during which they received interferon beta-1a only.
Final results are expected to be released late this year, but preliminary results have shown RHB-104 as an add-on therapy to be both safe and effective in reducing relapses. Encouraging 24-week interim findings were also reported on Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging (MRI) results.
RHB-104 is also being tested for Crohn’s disease in an ongoing Phase 3 clinical trial involving more than 200 patients in the U.S., Canada, Israel, Australia, New Zealand, and Europe (MAP US study, NCT01951326). RedHill expects to release interim results of this study later this year. The trial is still recruiting adult patients with moderately to severely active Crohn’s disease at its 95 study locations; those interested can learn more at its clinical trials.gov website.
“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,” Abramson said.
Available treatments for MS are intended to slow disease progression, prevent relapses, and reduce symptoms. As of 2015, more than 900,000 people worldwide were estimated to have MS, with approximately 85% initially diagnosed with RRMS.