CV Therapeutics, the Palo Alto biopharmaceutical company fending off unsolicited overtures from Japan’s second largest drug company, reported today that its new oral compound CVT-3619, designed to treat cardiometabolic diseases, was “well tolerated “with no serious adverse events and was associated with a reduction of free fatty acids.”
The Phase 1, single-blind, placebo-controlled, single-ascending-dose study involved 55 healthy and 23 obese volunteers. “No clinically meaningful changes in heart rate or blood pressure were observed in the study,” the company reported.
“Elevated (free fatty acid) levels cause insulin resistance and have emerged as a major link between obesity, metabolic syndrome and atherosclerotic vascular disease,” stated Dr. Guenther Boden, a professor of medicine at Temple University in Philadelphia, and chief of its section of endocrinology, diabetes and metabolism, adding that CV’s new drug candidate, “has great potential as a first-in-class pharmacological approach to normalize increased plasma FFA levels and address some of the downstream clinical consequences.”
The development is certain to fire up Tokyo-based Astellas Pharma’s determination to acquire CV Therapeutics, which has twice rebuffed its offer to buy the company for $16 a share and extended a poison pill provision designed to thwart hostile takeovers.