SRT501, a SIRT1 activator, is our proprietary formulation of resveratrol with improved bioavailability.

SRT501 was found to be safe and well tolerated in two Phase 1b clinical studies in patients with Type 2 Diabetes.  In the second Phase 1b trial, Type II Diabetic patients were given 1.25 or 2.5 grams of SRT501 orally twice daily for 28 days.  The patient group receiving 2.5 grams twice a day had significantly lower blood glucose levels as determined through an oral glucose tolerance test on day 28 at the test’s two-hour time point, as compared to the placebo group. 

At 2.5 grams twice daily, the study also found that SRT501 had a statistically significant lowering of both fasting blood glucose and glucose levels after meals, known as the postprandial period, an important timeframe for patients with Type 2 Diabetes who need better control of blood sugar levels after eating.

SRT501 is currently being tested in patients with Type 2 Diabetes in a Phase 2a study in combination with metformin, the current first-line therapy for Type 2 Diabetes. Results from this trial are expected in the second-half of this year.

SRT501 is also in a Phase 1b trial for MELAS syndrome (Mitochondrial myopathy, Encephalopathy, Lactic acidosis, and Stroke-like episodes). Sirtris expects data from this trial in the first half of 2009.  The United States Food and Drug Administration has granted the company orphan-drug designation for resveratrol in the treatment of MELAS syndrome.

The company plans to initiate a cancer trial with SRT501 in the second half of 2008.