SIRTRIS ANNOUNCES RESULTS FROM TRIALS OF SIRTUIN THERAPEUTIC
Sirtris Pharmaceuticals that the company's initial clinical candidate, SRT501, was found to be safe and well-tolerated when administered orally in two Phase I clinical studies. Based on this progress, Sirtris has initiated a Phase Ib study in patients with Type 2 Diabetes.
SRT501 targets SIRT1, a member of the human sirtuin family of enzymes. Specifically, SRT501 acts by increasing the number and function of mitochondria and so is therapeutically targeted to address diseases of aging including metabolic diseases, such as diabetes and obesity.
In the Phase I studies, SRT501 was administered orally once daily to 85 healthy male volunteers in separate study groups for seven days in order to evaluate dose, safety, tolerability and pharmacokinetics. SRT501 was found to be safe and well-tolerated, and there were no serious adverse events.
The company has initiated a Phase Ib trial in patients with Type 2 Diabetes. The trial is designed to evaluate the safety and the pharmacokinetics of SRT501 in 90 patients using daily oral administration of SRT501 for 28 days.