ARRAY-797 (Array Biopharma) reports Phase II results in Osteoarthritis

ARRAY-797 from Array Biopharma met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase II clinical trial in 157 Osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial.The investigational compound, ARRY-797, is a novel, oral, selective p38 inhibitor with a mechanism of action unique from that of currently approved pain medications. Treatment with ARRY-797 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 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). Additional endpoints, including WOMAC physical function, WOMAC stiffness, responder analysis and the Patient's Global Impression of Change, also showed improvement relative to placebo. Oxycodone ER was used as the active control for the trial. A higher discontinuation rate due to adverse events was observed in patients treated with oxycodone ER (34%) than for either the ARRY-797 (6%) or placebo (8%) treatment groups. In patients completing the trial, the reduction in WOMAC pain observed for ARRY-797 was comparable to that seen with oxycodone ER.