The European Patent Office (EPO) has issued a European patent covering the use of RedHill Biopharma's RHB-104 in the treatment of multiple sclerosis (MS).
MS is a chronic inflammatory, demyelinating disease of the central nervous system with an unknown etiology, which is believed to be multifactorial.
Patients with MS will have recurrent inflammatory attacks on the central nervous system (CNS) due to a dysfunctional immune system. The repeated attacks will lead to neurological disability.
RHB-104 is an oral antibiotic combination therapy, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
It is currently being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS), with an open-label, Phase IIa, proof-of-concept clinical study currently underway in Israel (the CEASE-MS study).
The Phase IIa CEASE-MS study follows 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.
RedHill Biopharma Intellectual property and research director Danielle Abramson said: “RHB-104 is a multifaceted drug which, in addition to bactericidal properties against intracellular infections, has potentially distinct mechanisms of action that include both anti-inflammation and neuroprotection.
“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.”
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).
Upon issuing of the grant, the patent will be valid in up to 38 European countries until 2032.