News Potential Relapsing MS Therapy, RHB-104, to Get New European Patent Potential Relapsing MS Therapy, RHB-104, to Get New European Patent by Joana Fernandes, PhD | August 30, 2016 Share this article: Share article via email Copy article link The European Patent Office has releasedĀ a Notice of Intention to Grant a new patent to support RHB-104 as a therapyĀ for relapsing-remitting multiple sclerosis (RRMS). RHB-104 is being developed Ā byĀ RedHill Biopharma. Patents covering the use of RHB-104 exist in over 25 countries, including the U.S., Australia, Canada, Japan, and in variousĀ European coutries. Once granted, the new patent will be active in 38 European statesĀ until 2032. āRHB-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,ā Danielle Abramson, PhD, director of Intellectual Property & Research at RedHill, said in a companyĀ press release. āThis new European patent is an important addition to RedHillās already robust patent portfolio covering ā¦Ā this potentially groundbreaking therapy.ā RHB-104 is an oral antibiotic combination therapy with anti-mycobacterial and anti-inflammatory properties. It isĀ under evaluation in a Phase 2a āproof-of-conceptā study for the treatment of RRMS in Israel (CEASE-MS study) that is now drawing to a close. In this trial, patients wereĀ 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 receivedĀ interferon beta-1a only. Final results are expected to be released late this year,Ā butĀ preliminaryĀ resultsĀ have shownĀ RHB-104 as an add-on therapy to be both safe and effective in reducing relapses. Encouraging 24-week interimĀ findingsĀ wereĀ also reported onĀ Expanded Disability Status Scale (EDSS) scores and brain magnetic resonance imaging (MRI) results. RHB-104 is also being tested for Crohnās disease in an ongoing Phase 3 clinical trial involvingĀ more than 200 patients in the U.S., Canada, Israel, Australia, New Zealand, and Europe (MAP US study,Ā NCT01951326). RedHill expects to releaseĀ interimĀ results of this study later this year. The trialĀ 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. āWe are very pleased with the progress achieved with the RHB-104 development programs for Crohnās 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,ā Abramson said. Available treatments for MS areĀ intendedĀ to slow diseaseĀ progression, prevent relapses, and reduce symptoms. As of 2015, more thanĀ 900,000 people worldwide were estimatedĀ to haveĀ MS, withĀ approximately 85%Ā initially diagnosed withĀ RRMS. Print This Page About the Author Joana Fernandes, PhD Joana brings more than 8 years of academic research and experience as well as Scientific writing and editing to her role as a Science and Research writer. She also served as a Postdoctoral Researcher at the Center for Neuroscience and Cell Biology in Coimbra, Portugal, where she also received her PhD in Health Science and Technologies, with a specialty in Molecular and Cellular Biology. Tags patent, RedHill Biopharma, RHB-104, RRMS
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