NicOx SA (SOPHIA ANTIPOLIS, France), a biopharmaceutical company focused on the development of nitric oxide-donating drugs targeting the therapeutic areas of inflammation and cardiometabolic disease, announced the initiation of the third pivotal phase III clinical trial for naproxcinod in patients with osteoarthritis (OA) of the hip. The 13-week, double-blind, controlled trial expects to enroll 800 patients at 100 clinical centers in the US, Canada, and Europe. The objectives of this study, the final trial in the company's plan for regulatory filing, is to demonstrate naproxcinod's efficacy, compared with placebo, in relieving the signs and symptoms of hip OA and to provide additional safety data, primarily to confirm naproxcinod's improved blood pressure (BP) profile compared with current treatments. Efficacy results are expected mid-2008.

NicOx intends to develop naproxcinod as the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class for treating the signs and symptoms of OA and believes naproxcinod has the potential to become the preferred drug, because it shows no detrimental effects on BP and a favorable gastrointestinal tolerability.

Eligible patients with a diagnosis of primary hip OA of at least 3-months' duration will be randomized to three arms: naproxcinod 750 mg bid, placebo bid, and naproxen 500 mg bid. Three coprimary endpoints will compare the efficacy of naproxcinod with placebo, based on the mean change between baseline and week 13 according to the following: the WOMAC pain subscale, the WOMAC function subscale, and the subject's overall rating of disease status. The study expects to show statistical significance for the superiority of naproxcinod on the three coprimary endpoints.

The initiation follows the successful results obtained in two earlier phase III studies of naproxcinod in patients with knee OA, which demonstrated superior efficacy, as well as a differentiated and potentially beneficial BP profile compared with naproxen. Nonsteroidal anti-inflammatory agents have a tendency to elevate BP and antagonize the beneficial effect of antihypertensive medications possibly increasing the rate of serious cardiovascular adverse events, such as heart attack and stroke.

NicOx expects to conduct a predefined statistical analysis in mid-2008 on the pooled BP data from all three phase III studies. The data will be included in the new drug application (NDA) to be submitted to the FDA in the first quarter of 2009.

—A. Techman