Sirtris Pharmaceuticals, Inc, a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging, released the phase Ib results of its first product SRT501.

The 28 day clinical study in patients with type 2 diabetes found out that SRT501 is safe and well-tolerated, and was found to significantly lower glucose in an oral glucose tolerance test conducted as part of the trial.

The study was designed to assess the safety, tolerability and pharmacokinetics of once-daily, orally administered doses of either 2.5 g or 5 g of SRT501 in patients with type 2 diabetes who were naive to other diabetes drug treatments. Both doses of SRT501 were found to be safe and well-tolerated, and pharmacokinetics, a measure of drug levels in the blood, were identical at days one and 28, suggesting no drug accumulation. There were no serious adverse events and no dose-related adverse events. SRT501 showed a statistically significant improvement in an oral glucose tolerance test on day 28 at two hours and a trend towards lower fasting plasma glucose levels.

SRT501 is also being tested in patients with type 2 diabetes in a phase Ib BID (twice daily administration) study and in a phase IIa study in combination with metformin, the current first-line therapy for type 2 diabetes. SIRT1 is the founding member of the human sirtuin family of enzymes which control the aging process. Specifically, SRT501 acts by increasing mitochondrial activity and therefore is targeted to address metabolic diseases, such as type 2 diabetes.

"This is the first time that a small molecule targeting sirtuins, the genes which control the aging process, has shown efficacy in a disease of aging," said Peter Elliott, Ph.D., senior vice president, Development, Sirtris. "These phase Ib study results are an important step forward for Sirtris because they represent significant progress in our clinical development of sirtuin therapeutics. We are very pleased to see the safety profile observed in preclinical studies translate into a well-tolerated drug molecule in patients, and we are very encouraged by the glucose lowering effects measured in the oral glucose test."

Sirtris Pharmaceuticals is a biopharmaceutical company focused on discovering and developing proprietary, orally available, small molecule drugs with the potential to treat diseases associated with aging, including metabolic diseases, such as type 2 diabetes.