RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.
Multiple Sclerosis is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system of uncertain etiology that exhibits characteristics of both infectious and autoimmune pathology. 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.
RedHill has succesfuly completed a Phase IIa proof of concept clinical study in Israel to assess the efficacy and safety of fixed dose combination RHB-104 as an add-on therapy to interferon beta-1a in patients treated for Relapsing Remitting Multiple Sclerosis (the CEASE MS study).
Encouraging top-line final results from the CEASE-MS study were announced in December 2016, demonstrating positive safety and clinical signals supporting therapeutic potential of RHB-104 in multiple sclerosis and further clinical development based on encouraging preliminary data.
The phase IIa CEASE-MS Study follows the successful completion of four pre-clinical studies with RHB-104, three of which were conducted using the experimental autoimmune encephalomyelitis (EAE) MS model.
The CEASE MS Phase IIa study is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.