A phase 2 trial to evaluate a potential treatment for Crohn’s disease is planned for an experimental drug that recently exhibited promising results in a trial involving ulcerative colitis (UC) patients.
The drug known as RPC1063, developed by Receptos Inc, was evaluated in a randomized, double-blind, placebo-controlled trial to assess the efficacy, safety, and tolerability of 2 orally administered doses (0.5 mg and 1 mg) in 199 UC patients in 13 countries. Clinical remission at week 8 was achieved by 16.4% of patients on the 1 mg dose of RPC1063, compared with 6.2% of patients on placebo.
In the 0.5-mg group, 13.8% of patients achieved clinical remission, which was not a statistically significant difference from the placebo group. Additionally, 58.2% of patients in the 1-mg dose group achieved clinical response, compared with 36.9% of patients in the placebo group.
The drug was generally well tolerated, with most adverse events across the active treatment and placebo groups either mild or moderate in nature. The results of the trial suggest RPC1063 may be used to treat Crohn’s disease, with a phase 2 study for the treatment of Crohn’s disease planned to occur in 2015.
“The consistency of the efficacy data across the various endpoints for the high dose, combined with the favorable safety profile, gives us confidence to move forward expeditiously with phase 3 trials in ulcerative colitis and a phase 2 trial in Crohn’s disease,” said Faheem Hasnain, president and chief executive officer of Receptos, in a press release. “There is a tremendous unmet need for a novel orally administered therapy in these patient populations. In addition, we believe that RPC1063 may have promise in other therapeutic areas, and we intend to continue to explore other autoimmune indications where RPC1063 may provide utility.” SPT