Indaflex misses Ph II endpoints

Canada's AlphaRx and USA-based Proprius Pharmaceuticals say that their co-developed topical non-steroidal anti-infalmmatory Indaflex (2.5% indomethacin cream) missed its primary endpoint in a Phase II trial in osteoarthritis of the knee. The randomized double-blind placebo and vehicle-controlled trial, which included a six-week treatment period, was conducted in 233 patients with OA of the knee. The primary endpoints used were the change from baseline to week six in the global Western Ontario and McMaster Universities Osteoarthritis Index score and the subject's global assessment.

While the trial did not meet its primary endpoints, subgroup analyses of patients with moderate-to-severe pain and more impaired physical function at baseline showed positive trends in patients treated with Indaflex versus those on either placebo or vehicle. The firm noted that the knowledge gained from this proof-of-concept study will guide pivotal trial design, adding that it will discuss the findings with the US regulator and advance Indaflex into registration trials.