Following the promising results of prior trials, Receptos, Inc., a biopharmaceutical company engaged in the treatment of immune and metabolic diseases, announced that the Phase 2 portion of the RADIANCE trial has met the primary endpoint, a reduction in MRI brain lesion activity in patients with relapsing multiple sclerosis (RMS).
The study was set to determine the efficacy, safety and tolerability of two orally administered doses of RPC1063, a selective sphingosine-1-phosphate (S1P1) receptor modulator, against placebo in a total of 258 patients suffering from RMS in 13 different countries.
Both primary and secondary endpoints of the trial were statistically significant, and patients receiving RPC1063 showed an 86% reduction of total gadolinium-enhancing (GdE) lesions, as determined by MRI, when compared to patients on placebo. Additionally, there was a favorable trend for RPC1063 patients regarding annualized relapse rate (ARR). Concerning safety and tolerability data, RPC1063 seems to hold a promising potential, since the general adverse events were similar to the placebo group, with no major safety issues for patients receiving the drug. In fact, heart rate changes and rates of liver transaminase elevations were low in patients receiving either dose of RPC1063.
Jeffrey Cohen, M.D., Principal Investigator of the RADIANCE trial and director of the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research, stated that “The results of this trial demonstrated a significant treatment effect of RPC1063 at both doses, consistent with other molecules in the class.” The researcher also highlighted the importance of the favorable overall safety profile of the drug and that the ongoing Phase 3 trial will explore these results in a more in-depth manner. This subsequent phase started in December 2013 under a Special Protocol Assessment with the FDA and is going to compare different doses of RPC1063 against interferon beta-1a (Avonex(R)) in 1,200 patients with RMS.
Faheem Hasnain, President and Chief Executive Officer of Receptos, stated that the positive results of the Phase 2 portion of RADIANCE could put RPC1063 as the best S1P receptor modulator, holding potential applications in other therapeutic areas, such as ulcerative colitis, a theory being explored in TOUCHSTONE, another Phase 2 clinical trial.