Recruitment complete in NicOx' Ph III HCT3012 trial

French drugmaker NicOx SA has completed patient enrollment in the first Phase III trial for HCT 3012, its drug candidate for osteoarthritis. The randomization of 820 patients with OA of the knee at 120 clinical sites in the USA was initiated in late December 2005 and has been completed ahead of its projected timelines, the firm noted. Results are anticipated in the fourth quarter of 2006.

The agent is a novel, proprietary, nitric oxide-donating derivative of naproxen, which NicOx aims to develop as the drug-of-choice for osteoarthritis patients, particularly those with co-existing hypertension, a key cardiovascular risk in up to 40% of the OA population. The Phase III trial is designed to demonstrate that HCT 3012 is superior to placebo and as effective as naproxen in relieving the signs and symptoms of the condition, in addition to showing that HCT 3012 has no detrimental effect on blood pressure, unlike all other non-steroidal anti-inflammatory drugs.