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Novel multiple sclerosis drug RPC1063 shows potential for treating UC

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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.

William J. Sandborn

“The results of this trial demonstrated a significant treatment effect of orally administered RPC1063 at the 1-mg dose, with what appears to be a clear dose response and consistency across both the primary and secondary efficacy endpoints,” William J. Sandborn, MD, chief of the division of gastroenterology at the University of California, San Diego, said in the press release. “The results also showed a favorable overall safety profile. A phase 3 program is clearly warranted in order to confirm and extend these results.”

A phase 3 program to compare the safety and efficacy of 1 mg RPC1063 to placebo in patients with UC will be initiated in 2015, according to the release, as well as a phase 2 study for treatment of Crohn’s disease.