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

The Phase III data, which was presented at the meeting of the American College of Rheumatology in Boston, Massachusetts, showed that both doses of naproxcinod (750mg and 375mg) had superior efficacy to placebo at all time points (2, 6 and 13 weeks). In addition, standard quality of life scores showed a functional improvement for both naproxcinod doses, as well as for patients taking naproxen 500mg.

Considering the data, “which is considered to be one of the leading events for the scientific and medical community in rheumatology", Thomas Schnitzer, a professor at Northwestern University Feinberg School of Medicine and the principal investigator on the study, called 301, said he was impressed. He said that nitric oxide “may exert a protective effect in the gastro-intestinal tract and play a homeostatic role in blood pressure control, so these Phase III results “suggest that naproxcinod may offer a promising clinical and pharmacological profile”. However Prof Schitzer stated that these findings will need to be confirmed by the ongoing 302 and 303 studies.

Data from the latter two studies are expected to be reported in mid-2008 and NicOx will then pool data from the three trials, before hopefully filing a New Drug Application for naproxcinod in the USA during the first quarter of 2009.