To further explore the safety and tolerability of ARRY-797, Array 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. ARRY-797 has been well-tolerated in this trial to date, and greater QTc prolongations were observed at these higher dose levels. No subject in either trial exhibited an absolute QTc interval >500 msec or a change from baseline >60 msec, two values cited by regulatory authorities, including the FDA, as thresholds of particular concern for cardiac arrhythmia. These QTc observations warrant further evaluation.
“These results, together with our earlier studies in acute pain, provide evidence that ARRY-797 delivers therapeutic utility in both acute and chronic pain settings,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “Given the scope of a development program in pain, Array will aggressively seek a partner to maximize the value of this drug.”
About the Osteoarthritis Trial
The Phase 2 trial was a 28-day double-blind, active- and placebo-controlled study in 157 patients with osteoarthritis of the knee who had moderate-to-severe chronic pain despite the use of NSAIDs. Patients were randomized (1:1:1) to receive ARRY-797, placebo or oxycodone ER while continuing their use of NSAIDs. The primary endpoint of the trial was the change in the WOMAC ® pain subscale from Baseline to Week 4 compared to placebo. Secondary endpoints included safety and pharmacokinetic assessments, WOMAC ® physical function subscale, WOMAC ® stiffness subscale, responder analysis and the Patient’s Global Impression of Change.About Osteoarthritis 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. A number of medications are currently available for the treatment of osteoarthritis pain, primarily NSAIDs and opioids; however, a significant unmet medical need remains. Opioids, although providing significant analgesic effects, are limited by tolerability issues (for example, somnolence, nausea, vomiting and constipation) and also suffer from the potential for abuse. NSAIDs offer only partial pain relief and are associated with renal, cardiovascular and gastrointestinal safety concerns.