Receptos Reports Positive Phase 2 Results For RPC1063 In RMS

(RTTNews) - Receptos, Inc. (RCPT) announced that the Phase 2 portion of the RADIANCE trial of its selective S1P1 receptor modulator, RPC1063, in relapsing multiple sclerosis or RMS met the primary endpoint, reduction in MRI brain lesion activity.

The company said the overall safety profile of RPC1063 was consistent with the results of prior trials, and continues to support the differentiation of the drug candidate against other oral agents for treatment of RMS on the market or in clinical development.

The randomized, double-blind study assessed the efficacy, safety and tolerability of two orally administered doses of RPC1063 against placebo in 258 patients with RMS across 77 sites in 13 countries. Patients on RPC1063 experienced a statistically significant reduction in GdE lesions of 86% at both 0.5 mg and 1.0 mg compared to patients on placebo. Secondary endpoints measuring effects on other MRI parameters were also positive and statistically significant. Although this Phase 2 portion of the trial was not powered to detect a statistically significant difference between RPC1063 treatment arms and placebo on annualized relapse rate or ARR, there was a favorable trend for both RPC1063 dose groups, the company stated.

Receptos said it initiated the Phase 3 portion of the RADIANCE trial under a Special Protocol Assessment with the FDA in December 2013. The Phase 3 portion of the trial, which is currently enrolling patients, is a randomized, double-blind study designed to compare 0.5 mg and 1.0 mg of RPC1063 against interferon beta-1a in 1,200 patients with RMS.