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Receptos Reports Positive Phase 2 Results for TOUCHSTONE Trial of RPC1063 in Ulcerative Colitis


This randomized, double-blind, placebo-controlled trial assessed the efficacy, safety and tolerability of two orally administered doses (0.5 mg and 1 mg) of RPC1063 in patients with UC across 57 sites in 13 countries. The trial enrolled 199 patients, approximately 10% higher than planned, due to a strong interest among investigators and patients to participate in the study. The primary endpoint of the trial, the proportion of patients in clinical remission at week 8 as defined by the industry standard Mayo scoring criteria, was achieved by 16.4% of patients on the 1 mg dose of RPC1063, as compared to 6.2% of patients on placebo, which was statistically significant (p<0.05). In the low dose group of 0.5 mg, 13.8% of patients achieved clinical remission, which was not statistically significantly different from the placebo group.

All secondary endpoints at week 8, including clinical response, change in the Mayo score and mucosal improvement on endoscopy were also positive and statistically significant for the 1 mg dose. Notably, 58.2% of patients on the 1 mg dose of RPC1063 achieved clinical response, as compared to 36.9% of patients on placebo (p<0.05). Trends were observed for all secondary efficacy endpoints for the 0.5 mg dose group that appear to demonstrate evidence of a dose response. The detailed results of the Phase 2 portion of the TOUCHSTONE trial are expected to be presented at a major scientific meeting in the coming months.

Looks like it is similar to entyvio in how it works but is orally administered.
Phase 3 for UC phase 2for CD coming soon.