NICOX REPORTS RESULTS FROM OSTEOARTHRITIS TRIAL

NicOx has announced results from a successful Phase III trial for naproxcinod (HCT 3012) in patients with osteoarthritis of the knee (the 301 study). Both doses of naproxcinod were shown to be superior to placebo on all three co-primary efficacy endpoints of the study. 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 class.

"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," Thomas Schnitzer, the trial's principal investigator, said.

In terms of the co-primary endpoints of the study, both of the naproxcinod doses (375 and 750 mg) were shown to be superior to placebo, with this being highly statistically significant in terms of the mean change from baseline at week 13 in the following scores: the WOMAC pain subscale, the WOMAC function subscale and patients' overall rating of disease status.

During the trial, patients' blood pressure was measured at each visit. Prespecified analyses of the difference between the blood pressure at baseline and the measurements at week two, six and 13, demonstrated that both naproxcinod 750 and 375 mg decreased systolic and diastolic blood pressure. This effect was sustained until the 13-week time point and clearly differentiated naproxcinod from naproxen.

Naproxcinod also showed good overall safety: 46.7 percent of the patients treated with naproxcinod 750 mg and 40.8 percent on naproxcinod 375 mg experienced at least one adverse event, compared to 56.4 percent on naproxen 500 mg and 38.7 percent on placebo. The number of serious adverse events was low and evenly spread among treatment groups. The number of adverse hypotensive events was low across all groups.