NicOx completes enrollment in naproxcinod ABPM trial

French drugmaker NicOx SA has completed subject enrollment in an ambulatory blood pressure monitoring trial of its investigational anti-hypertensive naproxcinod (HCT 3012). The randomization of 120 patients with stable essential hypertension at 16 clinical centers across the USA, which was initiated in May, has been completed ahead of schedule, with results anticipated in the fourth quarter.

The agent is a novel, proprietary, first-in-class COX-inhibiting nitric oxide-donator, which is currently in Phase III clinical development for the treatment of the signs and symptoms of osteoarthritis. Non-steroidal anti-inflammatory drugs represent the only established symptomatic treatment for the millions of patients who suffer from osteoarthritis worldwide. However, NSAIDs are known to raise blood pressure and antagonize the blood pressure-lowering effect of antihypertensives to an extent that may contribute to an increased incidence of cardiovascular events.

NicOx says that it hopes to develop naproxcinod as the drug-of-choice for the treatment of osteoarthritis, especially in those with co-existing hypertension, based on nitric oxide's ability to improve blood pressure control.