RPC1063 for RMS
RPC1063 is a novel, differentiated sphingosine 1-phosphate 1 receptor (S1P1) selective modulator exhibiting picomolar potency that is effective in rodent models of both multiple sclerosis (MS) and inflammatory bowel disease (IBD), and possesses an excellent safety profile in non-clinical toxicology studies. Receptos has completed a Phase 1 study with RPC1063 which tested single ascending doses, multiple ascending doses and dose titration regimens in healthy volunteers. The Phase 1 results confirmed optimal pharmacokinetic, pharmacodynamic and safety features, which provide supportive data for the differentiation strategy for RPC1063 as a potential best-in-class second generation S1P1 receptor modulator.
A Phase 2/3 study has been initiated to study RPC1063 in the indication of relapsing multiple sclerosis (RMS). RPC01-201, designed to demonstrate the clinical efficacy of RPC1063 in patients suffering from RMS, is a Phase 2/3 placebo-controlled (Phase 2) and active comparator-controlled (Phase 3) trial, and is the first of two planned pivotal studies for RPC1063 in RMS. Receptos anticipates initiating a second Phase 2 study with RPC1063 in ulcerative colitis in 2012.