Cerenis Therapeutics Reported Data from a Proof-of-Concept Phase I Study for the CER-627 Program
June 22, 2010
Cerenis Therapeutics SA, of Toulouse, France, reported data from a proof-of-concept Phase I study for the CER-627 program (niacin/aspirin combinations) showed that four days of predosing with 240 mg aspirin, followed by a simulated sustained-release aspirin treatment regimen, given in conjunction with 500 mg immediate-release niacin showed a significant 53 percent reduction in the Maximal Severity of Flushing compared to placebo. In a second Phase I study, which evaluated flushing induced by a single 2 g dose of extended-release niacin (Niaspin) with two different sustained-release aspirin-dosing regimens, showed a significantly reduced MSF of 37 percent compared to placebo for a regimen consisting of three days of predosing with 240 mg aspirin followed by aspirin 30 mg/kg for eight hours with extended-release niacin at hour four. A regimen that included no aspirin predosing, with aspirin 10 mg/hr for six hours with extended-release niacin at hour four resulted in no significant effect. Data were presented at the European Atherosclerosis Society Congress in Hamburg, Germany.
