NicOx initiates proof-of-principle clinical study for NCX 6560
First-in-man study for an innovative investigational drug, representing a global therapeutic approach for reduction of cardiovascular risk
NicOx S.A. announced the initiation of clinical development for NCX 6560, a novel, nitric oxide-donating compound which could become an improved investigational drug for serious cardiovascular diseases. The first-in-man study will enroll both healthy male volunteers and those with abnormally raised cholesterol and will compare NCX 6560 to placebo and atorvastatin (Lipitor®), with a preliminary evaluation of activity, safety and tolerability. The initiation of this study follows promising pre-clinical results which suggest NCX 6560 could inhibit multiple steps in the development of atherosclerosis, a key dysfunction underlying cardiovascular disorders.
“The initiation of clinical trials for NCX 6560 represents a major advance for the Company,” said Michele Garufi, Chief Executive Officer of NicOx. “This promising drug candidate is a new chemical entity discovered by our research laboratories, which has the potential to be developed in cardiovascular indications which go beyond lipid lowering. Moreover, this milestone confirms our strategic decision to grow as a research-driven pharmaceutical Company and expand our drug discovery projects in the cardiometabolic area, where nitric oxide plays a fundamental physiological role. We will continue to execute on this strategy, alongside our planned participation in the commercialization of naproxcinod.”
The objective of this phase 1 proof-of-principle study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of single and repeated escalating doses of NCX 6560. The trial will also follow a biomarker relevant to cardiovascular disorders, in order to provide the first evaluation of the compound’s activity in man and guide its future development.
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