Array BioPharma (ARRY) announced that ARRY-797 met its primary endpoint in a randomized, placebo-controlled and active-controlled , or oxycodone ER, Phase 2 clinical trial in 157 osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs or 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.
The company said that 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 this trial, ARRY-797 was considered overall to be well-tolerated at the selected dose of 400 mg twice-daily. The most common adverse events observed in patients treated with ARRY-797 were dizziness, diarrhea and nausea, which were mainly mild in severity.
The company said that, to further explore the safety and tolerability of ARRY-797, it is currently conducting a multiple ascending dose trial in healthy volunteers at doses up to 2.5-fold higher than those evaluated in the osteoarthritis pain trial.
Osteoarthritis, the most common form of arthritis, affects well over 20 million people in the U.S. and results in significant utilization of health care resources.
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