Positive Ph III for NicOx' naproxcinod

Sophia Antipolis, France-based NicOx SA has announced top-line results from a Phase III trial for naproxcinod (HCT 3012) in patients with osteoarthritis of the knee (the 301 study). Both doses of naproxcinod (750mg and 375mg bid) were shown to be superior to placebo on all three co-primary efficacy endpoints of the study, with these results being highly statistically significant (p<0.001).

Blood pressure data for both naproxcinod doses showed a sustained reduction versus baseline and naproxen, at all time points, confirming earlier published clinical data. Naproxcinod is the first compound in the COX-inhibiting nitric oxide-donating (CINOD) class, which NicOx aims to establish as the drug-of-choice for the treatment of osteoarthritis.

"The positive outcome of this pivotal trial for naproxcinod is an important step towards making this an efficacious and potentially safer treatment option for osteoarthritis patients," said Thomas Schnitzer, professor and Assistant Dean for Clinical Research at Northwestern University, USA, and principal investigator on the trial. "The blood pressure data showing a clear improvement against naproxen and from baseline is also extremely encouraging, in the light of the considerable need for a non-steroidal anti-inflammatory drug with an improved blood pressure profile," he added.