NicOx has announced that a Phase II trial for NCX 4016 in peripheral arterial obstructive disease (PAOD) has not met its primary endpoint in terms of demonstrating a statistically significant advantage over placebo. The primary endpoint of the trial was the change in absolute treadmill walking distance after six months of treatment, versus placebo, compared to baseline. A statistically significant advantage was seen for NCX 4016 in a pre-defined sub-group of patients with Type 2 diabetes. Full analysis of the data is ongoing, including an examination of pre-defined secondary end-points and safety and tolerability. NCX 4016 is a novel, proprietary, nitric oxide-donating derivative of acetylsalicylic acid, which NicOx is developing in a range of cardiovascular and related disorders.
The trial was a randomized, double-blind, placebo-controlled study, which enrolled 442 patients at 34 clinical sites throughout Europe. The trial enrolled patients with Leriche-Fontaine stage II PAOD (showing symptoms of intermittent claudication, or leg pain during walking). Eligible patients were randomized to treatment with either NCX 4016 800 mg bid. or placebo for six months. All patients also received low-dose aspirin. The primary objective of the study was to evaluate the clinical efficacy of NCX 4016 in PAOD and the primary endpoint was the change in maximal treadmill walking distance (absolute claudication distance) after six months, where NCX 4016 showed a non-significant advantage over placebo.