SRT501 Lowers Glucose in Twice-Daily Dosing Clinical Trial

I was browsing the internet this morning when I read this recent news about a clinical trial being conducted by Sirtris Pharmaceutical about a drug called SRT501 which, when administered twice daily to type 2 diabetic patients, found that the patient's group receiving 2.5 grams twice a day had significantly lower blood glucose levels(both fasting blood glucose and glucose levels after meals. This is the result of the Phase 1 of their study.

I am posting here the result of their study for your info and further reading.


Sirtris Announces SRT501 Lowers Glucose in Twice-Daily Dosing Clinical Trial; Study Suggests Dose Response for Proprietary Formulation of Resveratrol in Type 2 Diabetics

Clinical Trial Further Demonstrates Efficacy of SIRT1 Activation In Humans
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, today announced positive top-line data from its twice-daily dosing study of SRT501, the company’s proprietary formulation of resveratrol. The Phase 1b clinical trial, which tested either 1.25 or 2.5 grams of SRT501 given twice daily to Type 2 Diabetic patients, found that the patient group receiving 2.5 grams twice a day had significantly lower blood glucose levels as determined through an oral glucose tolerance test (OGTT) at the test’s two-hour time point, as compared with 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 Type 2 Diabetics who need better control of blood sugar levels after eating. While not at the level of statistical significance, this dose level also showed a strong trend in lowering postprandial insulin levels.

At 1.25 grams given twice daily, SRT501 also showed strong trends. While not at statistical significance, SRT501 at 1.25 grams given twice per day lowered fasting and postprandial glucose, and glucose when challenged with an OGTT at the two-hour time point on day 27 of the trial as compared to the placebo group. The data suggest a dose response.

The company plans to present the full data at the American Diabetes Association annual meeting in June.

“With this study, and the Phase 1b once daily dosing study data that we announced in January of this year, we have now observed a lowering of glucose in Type 2 Diabetic patients in two clinical trials with SRT501,” says Peter Elliott, Ph.D., Senior Vice President of Development at Sirtris. “The two Phase 1b clinical trials tested SRT501 at different dosage levels and dose time points. While the primary focus of each study was safety and blood levels of SRT501, by developing the studies as we did, we are also able to see signs of efficacy and dose response.”

“Our clinical trial program with SRT501 further validates our approach in targeting the SIRT1 enzyme for the development of a potential new treatment for Type 2 Diabetes,” says Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris. “Today’s Phase 1b announcement is the second time we’ve seen a translation of the positive results from preclinical studies carry over to humans.”

The current multi-center, blinded and randomized Phase 1b study included approximately 100 Type 2 Diabetic patients divided into three groups. The first patient group received 1.25 grams of SRT501 twice daily for a total daily-dose level of 2.5 grams. The second patient group received 2.5 grams twice daily for a total daily-dose level of 5.0 grams. The third group received placebo twice daily.

The study was designed to assess the safety, tolerability and pharmacokinetics of twice-daily, orally administered dosing of SRT501 at 2.5 and 5.0 total grams. In both patient cohorts receiving SRT501, the drug was found to be safe and well-tolerated, with no evidence of drug accumulation. The study also indicates that suitable pharmacokinetics, a measure of drug levels in the blood, was achieved.

In January of this year, Sirtris announced positive Phase 1b trial results of its once-daily dosing of SRT501 at 2.5 and 5.0 grams. In that study, SRT501 was also found to be safe and well-tolerated and to significantly lower glucose as compared to the placebo group in an OGTT at the two-hour time point as part of the 28 day trial of patients with Type 2 Diabetes.

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.

Sirtris has also identified new chemical entities (NCEs) that are chemically distinct from resveratrol, and in in-vitro tests are up to 1,000 times more potent. In preclinical models of Type 2 Diabetes, Sirtris’ NCEs have lowered glucose and improved sensitivity.


(Source: http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20080417005169&newsLang=en)