A Phase 2 clinical trial, TOUCHSTONE, evaluating Receptos' (RCPT +5.3%) ozanimod (RPC1063) for the treatment of ulcerative colitis (UC) met all of its efficacy endpoints with statistical significance after 32 weeks of treatment for the 1 mg dose.
The randomized, double-blind, placebo-controlled trial assessed two oral doses (0.5 mg and 1 mg) of ozanimod versus placebo in 199 patients with moderate-to-severe UC. In the induction period, all the primary and secondary endpoints were met after eight weeks of treatment. In the maintenance period, 103 patients who achieved a clinical response at Week 8 continued treatment for an additional 24 weeks. The proportion of patients in clinical remission at Week 32 was statistically significant for both dosage arms (p<0.05) compared to placebo. The full data will be presented a future scientific meeting this year.
The company plans to initiate a Phase 3 trial in 2015 in patients with moderate-to-severe UC as well as a Phase 2 study in Crohn's disease.
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