Array Phase 2 trial of ARRY-797 meets primary endpoint
Array BioPharma’s ARRY-797 has met primary endpoint in clinical proof of concept trial in osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs).
The treatment with oral, selective p38 inhibitor, resulted in a statistically significant reduction in pain over a 28-day period compared to placebo, as measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale (a 0 - 10 numerical pain rating scale).
Patients receiving ARRY-797 in the study experienced a mean reduction in the WOMAC pain subscale score at day 28 vs. baseline that was 0.8 greater than those receiving placebo (2.4 vs. 1.6; one-sided p = 0.0247).
The Altoona Arthritis and Osteoporosis Center founder and a study investigator Alan Kivitz said the study results with ARRY-797 showed promising benefit in the management of pain in osteoarthritis patients who are refractory to NSAIDS.
"This study was designed with a high hurdle in mind, which this drug was able to overcome," Kivitz added.
WOMAC physical function, WOMAC stiffness, responder analysis and the Patient's Global Impression of Change, additional endpoints, also showed improvement relative to placebo.
ARRY-797 was considered to be well-tolerated at the selected dose of 400mg twice-daily in the Phase 2 trial.