US-based biopharmaceutical firm Receptos has completed patient enrolment in the RADIANCE Phase III trial of ozanimod (formerly RPC1063) to treat relapsing multiple sclerosis (RMS).
Ozanimod is a new, oral, once-daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed for autoimmune indications including RMS and ulcerative colitis (UC).
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Due to strong interest among investigators and patients, the Phase III trial was over-enrolled by around 10%.
The company is continuing to enrol the SUNBEAM trial of ozanimod in patients with RMS and this Phase III clinical development programme is scheduled to be completed in the first half of 2017.
Both RADIANCE and SUNBEAM are randomised, double-blind Phase III trials designed to compare 0.5mg and 1.0mg of ozanimod against interferon beta-1a (Avonex) in 1,200 patients with RMS.
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Primary objectives of these trials are to evaluate whether ozanimod is superior to Avonex in reducing the annualized relapse rate in patients after two years of therapy and one year of therapy, respectively.
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By GlobalDataThe two trials are being conducted under special protocol assessment (SPA) agreements with the US Food and Drug Administration (FDA).
Receptos president and chief executive officer Faheem Hasnain said: "Completing enrollment of the RADIANCE trial represents another major corporate milestone for Receptos, and positions ozanimod as the potential next-to-market oral agent for the treatment of relapsing multiple sclerosis.
"Following positive Phase II results in ulcerative colitis, we also plan to initiate a Phase III programme for ozanimod in inflammatory bowel disease in 2015. We believe that ozanimod represents a potential franchise in immunology, and we continue to explore opportunities in other therapeutic indications where there is strong scientific rationale."
In September 2014, the company reported Phase II results, in which ozanimod met the primary endpoint of reduction in MRI brain lesion activity as well as secondary endpoints measuring effects on other MRI parameters.
