French biotechnology firm NicOx has presented another set of positive Phase III trial results for its lead investigational compound naproxcinod for the treatment of osteoarthritis.

The Sophia Antipolis-headquartered firm says that its third pivotal Phase III study for naproxcinod in patients with OA of the hip showed a “highly statistically significant result” on all three co-primary efficacy endpoints of the trial. The 13-week 303 study involved 810 patients with OA of the hip who were randomised on a 2:2:1 basis to receive naproxcinod 750mg, placebo and naproxen 500mg, respectively, twice-daily.

The results demonstrated that the NicOx drug, the first in a new class of anti-inflammatory drugs known as CINODs (COX-inhibiting nitric oxide-donators) was safe, effective and showed the same gastrointestinal adverse event rate and a similar blood pressure profile to placebo. Thomas Schnitzer of the Northwestern University Feinberg School of Medicine, who advised NicOx on the design and analysis of the trial, noted that few studies with other anti-inflammatories have focused only on people with hip OA, “in part because of the increased difficulty in demonstrating efficacy in this population compared to knee OA”. Additionally, “the fact that the blood pressure data for naproxcinod and placebo were similar at all time points is also encouraging,” he noted.

NicOx will now pool the blood pressure data from all three Phase III studies, according to a prospectively-designed protocol that has been submitted to the US Food and Drug Administration, and will disclose the top-line results of the analysis in the coming weeks. A New Drug Application is expected in mid-2009 and the firm is looking for a partner to help market naproxcinod.

The results from the 303 study have gone down well with investors and NiCox shares ended the day up 19.3% at 11.11 euros.