Third pivotal phase 3 study for NicOx’ naproxcinod shows positive efficacy, safety and blood pressure results

25-Nov-2008 - France

NicOx S.A. announced that the third pivotal phase 3 study for naproxcinod in patients with osteoarthritis (OA) of the hip showed a highly statistically significant result (p<0.001) on all three co-primary efficacy endpoints of the trial. Naproxcinod 750 mg bid showed the same gastrointestinal (GI) adverse event rate and a similar blood pressure profile to placebo. Naproxcinod is the most advanced compound in a novel class of anti-inflammatory agents known as Cyclooxygenase-Inhibiting Nitric Oxide Donators (CINODs).

Following the positive results from the 301 and 302 studies in patients with OA of the knee, 303 represents the third phase 3 study for naproxcinod to achieve p<0.001 on all three co-primary efficacy endpoints. The 303 study is also the final pivotal trial that NicOx plans to include in the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in mid-2009.

“This study has demonstrated clear-cut efficacy for naproxcinod 750 mg bid in hip OA, in addition to providing reassuring blood pressure and safety data,” said Thomas J. Schnitzer, MD, PhD, Professor of Medicine at Northwestern University Feinberg School of Medicine, who advised NicOx on the design and analysis of the trial. “Meeting the primary endpoints of this study is a significant achievement, considering the difficultly in controlling the symptoms of hip OA patients. Few studies with other anti-inflammatory agents have focused only on people with hip OA, in part because of the increased difficulty in demonstrating efficacy in this population compared to knee OA. Additionally, the fact that the blood pressure data for naproxcinod and placebo were similar at all time points is also encouraging, as there is a definite need for new anti-inflammatory agents that do not increase blood pressure.”

As planned, NicOx will pool the blood pressure data from the three phase 3 studies (301, 302 and 303) according to a prospectively designed protocol that has been submitted to the FDA. The Company will disclose the top-line results of the pre-specified statistical analysis on the pooled data in the coming weeks.

https://www.bionity.com/en/news/90167/third-pivotal-phase-3-study-for-nicox-naproxcinod-shows-positive-efficacy-safety-and-blood-pressure-results.html