Array BioPharma (Array) has reported its preliminary analysis of results from a study examining ARRY-162, a small molecule MEK inhibitor, in a 12-week phase 2 clinical trial with 201 patients.
The study included a placebo group and three different dose groups of ARRY-162, all on a stable background of methotrexate drug.
Reportedly, none of the treatment groups demonstrated a significant ACR20 response rate compared to the placebo group at 12 weeks, therefore the study did not meet the primary endpoint.
The company said that the overall placebo response rates in the study were higher than expected for the patient population and showed regional differences, with patients in South America having substantially higher placebo response rates than those in Eastern Europe.
Array is conducting a full analysis of safety, efficacy and pharmacokinetic data from the study and expects to present complete results at a medical conference in 2010.
Kevin Koch, president and chief scientific officer at Array, said: “This is the first clinical trial evaluating the modulation of the MEK pathway for the treatment of chronic inflammatory disease.
“While we are disappointed in the overall efficacy outcome, we were pleased with the confirmation of the favorable safety profile and are continuing to evaluate the regional results. Previously we announced our strategy to rapidly advance ARRY-162 for the treatment of cancer patients. We initiated a phase 1 oncology trial last month and patient dosing is underway.”