Receptos, Inc., announced today that its selective sphingosine‐1‐ phosphate 1 receptor (S1P1R) modulator, RPC1063, has been administered to the first patient in a Phase 2 study examining the clinical efficacy and safety of induction therapy in patients with moderately to severely active ulcerative colitis (UC).
Leading to the initiation of the RPC01-202 study, called TOUCHSTONE, Receptos successfully filed an Investigational New Drug (IND) Application with the Division of Gastroenterology and Inborn Errors Products (DGIEP) of the United States Food and Drug Administration (USFDA). Receptos also has an active IND for RPC1063 with the Division of Neurology Products (DNP), under which an ongoing Phase 2/3 study for RPC1063 in Relapsing Multiple Sclerosis (RMS) is being enrolled.
TOUCHSTONE is a multi-national, multi-center, double-blind, randomized, placebo-controlled study investigating the effect of two active doses of RPC1063 versus placebo. The study is designed to enroll approximately 180 patients in North America, Europe and Asia Pacific. The primary objective of TOUCHSTONE is to compare the efficacy of RPC1063 for the induction of clinical remission in patients with moderately to severely active UC at eight weeks of treatment.
Receptos Doses First Patient in Phase 2 Trial for RPC1063 in Ulcerative Colitis
PR Newswire (press release)
“RPC1063 not only has the potential to demonstrate efficacy in both induction and maintenance therapy for ulcerative colitis, but could represent a first-in-class offering for S1P1R modulation as a novel mechanism of action to treat inflammatory bowel …and more »