NicOx has reported that a phase 1b, first-in-man study for NCX 6560, versus placebo and Lipitor (atorvastatin), has met its primary and secondary objectives. The primary top-line results reportedly demonstrated safety and tolerability for all the tested doses of NCX 6560, as well as the expected cholesterol lowering profile.
The company said that secondary objectives were also met, with single and multiple ascending doses showing a favourable pharmacokinetic profile.
NCX 6560 is a nitric oxide (NO)- donating HMG-CoA reductase inhibitor, which has the potential to be developed as a new treatment to further reduce the risk of major adverse cardiac events (MACEs) in Coronary Heart Disease (CHD) patients.
In the first part of the study, 40 healthy male volunteers received a single dose of either NCX 6560 or placebo. In the second part, 48 male volunteers with high levels of low density lipoprotein (LDL) cholesterol received NCX 6560 (repeated escalating doses), atorvastatin (at marketed dose) or placebo once-daily for 14 days.
The preliminary evaluation of the cholesterol-lowering effect in subjects with high LDL-cholesterol at baseline, the most important exploratory objective, showed strong activity for NCX 6560 with a dose-related LDL- cholesterol decrease. The highest dose tested reached approximately a 60% reduction after only two weeks of treatment.
The third part of the study enrolled 10 healthy male volunteers who had received the highest tolerated dose of NCX 6560 in the first part of the study. The volunteers stayed in the same treatment arm (NCX 6560 or placebo) but the dose was administered following a high-fat breakfast. Interestingly, no apparent food effect was observed for NCX 6560.
Pascal Pfister, chief scientific officer and head of research and development at NicOx, said: “The role of NO in preventing pathological processes in the vasculature suggests NCX 6560 could have the potential to reduce the occurrence of serious cardiovascular adverse events, such as stroke and heart attack, in Coronary Heart Disease patients. In light of these results, we are keen to see NCX 6560 advanced into phase 2.”