US-based biopharmaceutical firm Receptos has enrolled the first patients in the Phase III portion of RADIANCE, its Phase II/III trial of RPC1063 in relapsing multiple sclerosis (RMS).
The move follows the review of interim analysis of the Phase II portion of the trial which was announced in December 2013.
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RPC1063 is a novel, oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator being developed for autoimmune indications.
The RADIANCE Phase II/III trial was designed to speed-up the RMS clinical development programme for RPC1063 by enabling advancement into Phase III in a rapid fashion and eliminating the delay that typically exists between the completion of a Phase II trial and the start of a subsequent Phase III trial.
The company said that many of the clinical trial sites involved in Phase II are also participating in Phase III of the trial, allowing for efficient enrolment of Phase III patients that are separate from the Phase II patient population.
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In addition, the company has secured special protocol assessment (SPA) agreement from the US FDA on the clinical trial design for both the Phase III portion of RADIANCE, as well as a second planned RMS Phase III trial.
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By GlobalDataThe second Phase III trial is planned to start following the announcement of the top-line results of Phase II portion of the RADIANCE trial, which is expected to occur in mid-2014.
Receptos president and chief executive officer Faheem Hasnain said the start of Phase III positions RPC1063 as the potential next-to-market sphingosine 1-phosphate 1 receptor (S1P1R) modulator for the treatment of relapsing multiple sclerosis.
"Since the founding of Receptos in 2009, we have made rapid progress in the development of RPC1063, which we believe may represent a best-in-class molecule in the S1P1R modulator class," Hasnain said.
"In addition to the top-line results of the Phase 2 portion of RADIANCE, we also look forward in mid-2014 to the top-line results of TOUCHSTONE, our Phase 2 study of RPC1063 in ulcerative colitis, as well as continued progress with our pipeline programmes."
The randomised, double-blind Phase II portion of the RADIANCE trial is designed to compare 0.5mg and 1.0mg of RPC1063 against placebo in patients with RMS.
A total of 258 patients were enrolled in the Phase II trial in October 2013, while the actual planned number was 210 patients.
The randomised, double-blind Phase III portion of the trial is designed to compare 0.5mg and 1.0mg of RPC1063 against interferon beta-1a (Avonex) in 1,200 patients with RMS.
The company is also enrolling a randomised Phase II study, called TOUCHSTONE, evaluating the efficacy, safety and tolerability of RPC1063 in ulcerative colitis (UC).
According to the company top-line results of both the trials are expected to be released in mid-2014.
Image: Photomicrograph of a demyelinating multiple sclerosis-Lesion. Photo: courtesy of Marvin 101.
