Sirtris Pharmaceuticals, a biopharmaceutical company focused on developing small molecule drugs to treat diseases such as Type 2 diabetes, reported that its SRT501 was found to be safe, well-tolerated and to significantly lower glucose in an oral glucose tolerance test conducted as part of a 28-day Phase 1b clinical study in patients with Type 2 Diabetes.
The 28-day Phase 1b 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 had not experienced other diabetes drug treatments.
The Cambridge, Mass.-based Sirtris said 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. There were no serious adverse events and no dose-related adverse events. Also, 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, Sirtris reported.
SRT501 is also being tested in patients with Type 2 Diabetes in a Phase 1b BID (twice daily administration) study and in a Phase 2a 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 that are believed to slow the aging process. SRT501, a reformulation of resveratrol, is the same substance found in red wine. The company said the drug acts by increasing mitochondrial activity and therefore is targeted to address metabolic diseases, such as Type 2 diabetes.
Christoph Westphal, MD, PhD, CEO and vice chair of Sirtris, said “SRT501 may represent a promising treatment option for these [Type 2 diabetes] patients. We look forward to obtaining the results from our other Phase 1b clinical trial and the results from our Phase 2a clinical trial later this year.” He added that the drug needs to endure several longer, larger clinical trials before it can seek FDA approval, but the company hopes to bring its first drug to market in 2012 or 2013.
The company expects to release the safety data from its twice-a-day trial within the first half of this year.