RPC1063: Phase II data

The double-blind, international Phase II TOUCHSTONE trial in 199 patients with moderately to severely active UC showed that once-daily 1 mg oral RPC1063 for 32 weeks met the primary endpoint of improving the proportion of patients in clinical remission, defined as Mayo score of <=2 points with no individual subscore of >1 point, at week 8 vs. placebo (16.4% vs. 6.2%, p<0.05). The once-daily 0.5 mg dose of RPC1063 missed the primary endpoint, with 13.8% of patients achieving clinical remission at week 8 (p=not significant). High-dose RPC1063 also met all secondary endpoints at week 8 vs. placebo, including a greater proportion of patients with a clinical response at week 8 (58.2% vs. 36.9%, p<0.05). RPC1063 was generally well tolerated and the incidence of adverse events was similar between treatment groups. The trial also includes a 24-week maintenance period in patients who achieved a clinical response at week 8, with data expected next year. ...