NicOx announced that NCX 6560, its drug candidate for high cholesterol, met its primary and secondary endpoints in a Phase Ib man-in study. The drug demonstrated top-line safety and tolerability, along with cholesterol-lowering effects, at all tested doses. NCX 6560 was tested against a placebo and Pfizer‘s Lipitor (atorvastatin).
In the first part of the study, 40 healthy male volunteers received either NCX 6560 or a placebo. In the second part, 48 males with high levels of low-density lipoprotein (LDL), or “bad” cholesterol, were given either NCX 6560, a placebo, or atorvastatin for 14 days. The highest tested dose of NCX 6560 was found to have a safety profile comparable to that of atorvastatin, and reduced LDL cholesterol by 60 percent after two weeks of treatment.
The third part of the study involved administering the highest doses of NCX 6560 after a high-fat breakfast. Food was not found to have an effect on the drug’s performance.
NicOx is a French pharmaceutical company that uses the properties nitrous oxide to develop drugs. Their pipeline includes drug candidates for osteoarthritis, glaucoma, allergic rhinitis and hypertension. Nitrous oxide is thought to play a key role in the development of cardiovascular diseases such as atherosclerosis and thrombosis. NCX 6560 is a nitrous oxide-donating compound intended to benefit the heart beyond is cholesterol-lowering properties.
Increased levels of LDL cholesterol are associated with the development of cardiovascular disease. Other companies developing cholesterol-lowering drugs include Kowa Pharmaceuticals, Forbes Medi-Tech, and VIA Pharmaceuticals.