NICOX'S TRIAL OF NAPROXCINOD MISSES PRIMARY ENDPOINT

NicOx has announced results from a Phase I pharmacodynamic clinical study that compared naproxcinod with naproxen using ambulatory blood pressure monitoring (ABPM), which demonstrated a differentiated and favorable 24-hour blood pressure profile for naproxcinod, in hypertensive subjects.

The trial results showed a 2-mmHg difference in both the average systolic and diastolic blood pressure in favor of naproxcinod, in terms of the mean change from baseline as measured by ABPM. This difference did not reach statistical significance for systolic blood pressure, the primary endpoint of the trial. However, statistical significance was achieved for diastolic blood pressure. Naproxcinod is a first-in-class Cox-inhibiting nitric-oxide-donator being developed to treat osteoarthritis.

The magnitude of the blood pressure differentiation seen for naproxcinod in this trial is consistent with that observed after two weeks in the recently announced successful Phase III efficacy trial in osteoarthritis patients. The efficacy trial showed a reduction in systolic and diastolic blood pressure versus baseline and naproxen, which was sustained over the full 13 weeks of the study. The pharmacodynamic study was designed to provide complementary blood pressure data to the Phase III program by using an ABPM device to assess the 24-hour blood pressure profile of naproxcinod and naproxen in stable hypertensive subjects at two weeks.

The ABPM trial enrolled 131 volunteer subjects with stable essential hypertension at 15 active clinical centers in the United States. The subjects were not osteoarthritis patients but were between 50 and 75 years old, in order to be representative of the osteoarthritis population. Subjects were randomized to one of two groups: half were given 750 mg of naproxcinod, twice-daily for 14 days, followed by 500 mg of naproxen, twice-daily for 14 days, and the other half received the compounds in the opposite order. Placebo was administered during wash-out periods.