Sirtris initiates Ph IIa trial of SRT501

Cambridge, Massachusetts, USA Sirtris Pharmaceuticals, a biopharmaceutical company focused on small-molecule drugs to treat diseases of aging, has initiated a Phase IIa clinical trial in India to evaluate its SRT501 product candidate in patients with type 2 diabetes whose glucose levels are not adequately controlled by their metformin treatment, a current first-line therapy for such patients.

Patients on metformin alone that have an HbA1c level greater than 7.5%, which suggests that their glucose levels are not adequately controlled by current treatment, will be allowed to enter this randomized, double-blind, placebo-controlled Phase IIa trial. Such patients will continue on their current metformin therapy together with either SRT501 or placebo, which will be administered once daily for three months, noted the firm. The trial is expected to enroll 130 patients and results are anticipated at the end of 2008.

The agent is Sirtris' proprietary version of resveratrol, a natural antioxidant which improves mitochondrial function and protects against metabolic disease. Specifically, SRT501 acts by increasing mitochondrial activity in preclinical models of disease, and the firm believe it may be therapeutic for metabolic diseases like type 2 diabetes as well as mitochondrial disorders such as MELAS Syndrome.