NicOx S.A. announced the completion of patient enrolment in the third pivotal phase III clinical trial for naproxcinod, in patients with osteoarthritis of the hip (the 303 study). 810 patients have been randomized in 120 clinical centre in North America and Europe in this study, which is the final phase III trial in 'NicOx' clinical plan for the regulatory filing of naproxcinod.
The objective of this study is to assess naproxcinod's efficacy in relieving the signs and symptoms of osteoarthritis of the hip and provide additional safety data, including further information on naproxcinod's blood pressure profile in comparison to another anti-inflammatory medication. Results from this study are expected in Q4, 2008 and NicOx projects the filing of a New Drug Application (NDA) in mid-2009.
NicOx is currently in the final stages of developing naproxcinod as an investigational drug for treating the signs and symptoms of osteoarthritis. Naproxcinod is the most advanced compound in a novel class of anti -inflammatory agents known as the Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs). The 303 study follows the previous two pivotal phase 3 trials. Successful results were obtained in the 301 phase III study, in patients with osteoarthritis of the knee (see press release of October 27, 2006). These data demonstrated superior efficacy to placebo. Data collected suggested that naproxcinod could have no detrimental effect on blood pressure, in contrast to naproxen, a widely used non-steroidal anti-inflammatory drug (NSAID). NSAIDs are known to have the tendency to elevate blood pressure to an extent that may increase the rate of serious cardiovascular adverse events, such as heart attack and stroke .
The 302 study for naproxcinod in patients with osteoarthritis of the knee (see press release of April 3, 200 7) is due to report results in Q3 2008.
Maarten Beekman, vice president of Clinical Development at NicOx, commented: "The completion of patient enrolment in this pivotal phase III trial for naproxcinod is a further important step in our plan for the regulatory filing of the first CINOD in the US and Europe. The enrolment of 810 hip osteoarthritis patients in less than a year is a significant achievement, due to the lower availability of these patients for clinical studies and the strict protocol criteria necessary for this study. Medical literature from other anti-inflammatory agents shows that hip osteoarthritis studies have produced a lower rate of positive efficacy results than knee studies. Nevertheless, we believe the stringent criteria applied to the 303 study give us a good probability of achieving a positive result on the primary endpoint."
NicOx a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease.