NicOx completes enrollment in Phase III osteoarthritis study

The 302 study for naproxcinod was initiated in April, 2007 and is being conducted by Premier Research Group. This study is a 53-week, randomized, double-blind, efficacy and safety trial in which 1020 patients with osteoarthritis of the knee have been enrolled at 150 clinical sites throughout the US. Patients have been randomized to one of the following treatment groups: naproxcinod 375mg bid (52 weeks), naproxcinod 750mg bid (52 weeks), naproxen 500mg bid (52 weeks) and placebo bid during the first 13 weeks. After 13 weeks, the placebo treated patients are being randomized to either naproxcinod 375mg bid or naproxcinod 750mg bid for the remainder of the trial (39 weeks). Patients have primary osteoarthritis of the knee of at least 3 months duration. The trial has recruited both hypertensive and non-hypertensive patients, although patients with uncontrolled hypertension have been excluded.

The two doses of naproxcinod (750mg and 375mg bid) will be compared to placebo on three co-primary efficacy endpoints, based on the mean change between baseline and week-13 in the following scores: the Womac pain subscale, the Womac function subscale and subject’s overall rating of disease status. These are the standard endpoints used to demonstrate the efficacy of drugs for treating the signs and symptoms of osteoarthritis and are the same as those used in the other two pivotal Phase III studies for naproxcinod. A secondary endpoint of the trial is to compare the efficacy of naproxcinod and naproxen at 26 weeks. The general safety and tolerability of naproxcinod are assessed until week-52 and the trial has a 1-week post-treatment safety period.

Patients’ blood pressure is being assessed during each visit to the treatment center, using controlled Office Blood Pressure Measurements (OBPM). The blood pressure effect of naproxcinod will be assessed in the overall population and a sub-group of hypertensive subjects. Various secondary endpoints will compare the different treatments in terms of the mean change from baseline in systolic and diastolic blood pressure, at a range of time points. Additional secondary endpoints will assess the appearance of new hypertension or worsening of pre-existing hypertension. Efficacy results from this study are anticipated in the third quarter of 2008.

NicOx now anticipates the filing of a new drug application for naproxcinod with the FDA in mid-2009. Naproxcinod is the company’s lead investigational drug product and the first compound in the cox-inhibiting nitric oxide-donating (CINOD) class.