NicOx S.A announced that a phase-1b, first-in-man study for NCX 6560, versus placebo and Lipitor (atorvastatin), has met its primary and secondary objectives. The top-line results demonstrated very good safety and tolerability for all the tested doses of NCX 6560, as well as the expected cholesterol lowering profile. NCX 6560 is an innovative 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.

“These positive first-in-man results for NCX 6560 are an important step forward and show a very good safety and tolerability profile, even at high doses,” declared James Shepherd, professor of Cardiovascular and Medical Sciences at the University of G lasgow. “The numerous roles of nitric oxide deficiency in the development of cardiovascular disorders have been studied extensively in the past decades. NCX 6560 represents a promising drug candidate, as it could target a number of the biochemical and physiological processes which lead to the most common cardiovascular diseases.”

Statins are the most effective drugs for lowering abnormally raised cholesterol, however, there is a clear need for novel treatment options capable of further reducing MACEs and mortality. Evidence suggests that statins have some beneficial effects beyond cholesterol lowering, which are believed to be derived from their propensity to enhance NO biosynthesis.

Abnormally low NO release from the vasculature is believed to play an important role in the key processes underlying the most common cardiovascular disorders, such as endothelium dysfunction, atherosclerosis and thrombosis. NCX 6560 is a New Chemical Entity (NCE) that is an NO-donating atorvastatin, which is designed to provide broadened and increased beneficial effects.