NicOx initiates second Ph III trial of naproxcinod

French drugmaker NicOx SA has initiated the second pivotal Phase III trial for its drug candidate naproxcinod in patients with osteoarthritis of the knee (the 302 study). The trial is expected to enroll approximately 1,020 patients at 120 centers in the USA, and the firm hopes it will confirm naproxcinod's efficacy and provide additional blood pressure data, a key factor to differentiate the agent from existing treatments. Efficacy data are expected in the middle of next year.

Naproxcinod is the first compound in the COX-inhibiting Nitric Oxide-Donating (CINOD) class, which NicOx aims to develop as the drug-of-choice for the signs and symptoms of osteoarthritis. The initiation of 302 follows the successful results obtained for naproxcinod in previous Phase II and Phase III trials, which showed superior efficacy to placebo and no detrimental effect on blood pressure, when compared to existing non-steroidal anti-inflammatory drugs, widely used products associated with worrying side effects, including the tendency to raise blood pressure to an extent that may increase the rate of cardiovascular adverse events.

NicOx chief executive Michele Garufi said he foresees the filing of a New Drug Application in the USA during the first quarter of 2009. In the 53-week, randomized, double-blind, efficacy and safety trial, patients with osteoarthritis of the knee will be randomized to one of two doses of naproxcinod or placebo.