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.
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.