Receptos To Initiate Late-stage Trial Of RPC1063 In Relapsing Multiple Sclerosis

(RTTNews) - Receptos Inc. (RCPT) announced Thursday that it has completed a pre-planned interim analysis of the Phase 2 portion of RADIANCE, its Phase 2/3 trial of RPC1063 in relapsing multiple sclerosis or RMS. The Data Monitoring Committee or DMC reviewed data from the interim analysis of the study and approved continuation of the Phase 2 portion as well as initiation of the Phase 3 portion of the study.

The company stated that the results continue to support the RPC1063 differentiation profile and are consistent with data from prior RPC1063 studies. Based on the results of the interim analysis and the DMC recommendation, the company noted that it will initiate the Phase 3 portion of RADIANCE. Top-line results of the Phase 2 portion of the study continue to be expected in mid-2014.

The company said the following preliminary observations of the interim data were made with regard to key aspects of the product profile: The overall adverse event profile appears relatively balanced between RPC1063 and placebo groups, with no serious adverse events observed to date;Modest impact on heart rate for RPC1063-treated patients compared to placebo patients, consistent with results of the earlier RPC1063 thorough QT study, with no cardiac adverse events observed to date.

Low rates of liver enzyme elevations observed in study to date that appear supportive of a favorable hepatotoxicity profile; Preliminary clinical activity and reduction in lymphocyte count that appear to be consistent with data from other S1P receptor modulators on the market or in development.

RPC1063 is a novel, oral, once daily, selective and potent sphingosine 1-phosphate 1 receptor (S1P1R) modulator in development for autoimmune indications.