Israeli biopharmaceutical company RedHill Biopharma has started screening patients for a Phase IIa trial designed to evaluate the efficacy and safety of RHB-104 in multiple sclerosis.
Conducted at two centres, the open-label study will enrol sixteen relapsing remitting multiple sclerosis (RRMS) patients to assess RHB-104 after 24 weeks of treatment, and for the subsequent 24 weeks.
A patent-protected combination therapy of three antibiotics in a single capsule, RHB-104 will be assessed as an added therapy to interferon beta-1a in patients treated for RRMS.
RedHill RHB-104 MS product manager Clara Fehrmann said the medical community had an increasing awareness about the possibility of a bacterial-induced dysregulated immune system playing a major role in the pathogenesis of MS.
"It is RedHill’s hope that the CEASE-MS study will demonstrate RHB-104’s potential to become an effective treatment option for patients with MS," Fehrmann said.
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The study’s primary endpoint is the number of combined unique active lesions after treatment compared to baseline, whereas changes in pro-inflammatory cytokine markers, Mycobacterium avium subspecies paratuberculosis (MAP) status, relapse rate, expanded disability status scale (EDSS) and safety and tolerability of RHB-104 form the secondary endpoints.
CEASE-MS study principal investigator Dr Radi Shahien of Ziv Medical Center said; "The CEASE-MS study with RHB-104 aims to test this new hypothesis to the etiology of MS."
The CEASE-MS study follows successful completion of four pre-clinical studies, and currently recruitment is ongoing in the US, Canada and Israel for a Phase III trial of RHB-104 to treat Crohn’s disease.
Phase III trial is scheduled to commence by the third quarter of 2013.
Image: Photomicrograph of a demyelinating MS lesion. Photo: Courtesy of Marvin 101.
