October 31, 2014
RPC1063, a sphingosine 1-phosphate 1 receptor small molecule modulator candidate for immune indications such as relapsing multiple sclerosis, demonstrated safety and efficacy in the treatment of patients with ulcerative colitis in a recent phase 2 clinical trial, according to a press release from the manufacturer.
The TOUCHSTONE trial included 199 patients with moderately to severely active UC from 57 centers in 13 countries who were randomly assigned 0.5 mg or 1 mg RPC1063 (Receptos) or placebo. There was an 8-week induction period followed by a 24-week maintenance period, which is ongoing and scheduled to be completed in 2015. Clinical remission was achieved at week 8 by 16.4% of patients in the 1-mg group vs. 6.2% of the placebo group (P<.05), and 13.8% of the 0.5-mg group achieved clinical remission. Clinical response was achieved by 58.2% of patients in the 1-mg group compared with 36.9% of the placebo group (P<.05). Positive changes in Mayo score and mucosal improvement also were achieved by patients in the 1-mg group, and similar trends were observed in the 0.5-mg group. RPC1063 also appeared to be well tolerated.