Wednesday, July 18, 2007

Clinical Trials

Sirtris Pharmaceuticals Presents Results of Studies of SIRT1 Activators at 6th Annual Metabolic Diseases Drug Discovery and Development World Summit, July 17, 2007
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 17, 2007 - Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging, announced today that it presented data from pre-clinical and Phase 1a studies at the 6th Annual Metabolic Diseases Drug Discovery and Development World Summit in San Diego, California on July 17, 2007. As previously announced, Jill Milne, Ph.D., Senior Director of Biology at Sirtris, delivered a keynote address "SIRT1 Activation: A Novel Mechanism for Treating Type 2 Diabetes."
Dr. Milne presented data which showed that SRT501, Sirtris' proprietary formulation of resveratrol, reduces glucose and improves insulin sensitivity in multiple pre-clinical models of Type 2 Diabetes. Dr. Milne also presented pharmacokinetic (PK) data from a Phase 1a study conducted by Sirtris in which healthy volunteers who were dosed with SRT501 had an improved exposure as compared with other published studies. Both the area under the curve concentrations (AUC) as well as the maximal concentrations (Cmax) were shown to be improved with SRT501 as compared with literature values for resveratrol. SRT501 is currently being tested in a Phase 1b study in patients with Type 2 Diabetes.

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About Sirtris Pharmaceuticals

Sirtris Pharmaceuticals Presents Results of Studies of SIRT1 Activators at 6th Annual Metabolic Diseases Drug Discovery and Development World Summit, July 17, 2007 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 17, 2007 - Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging, announced today that it presented data from pre-clinical and Phase 1a studies at the 6th Annual Metabolic Diseases Drug Discovery and Development World Summit in San Diego, California on July 17, 2007. As previously announced, Jill Milne, Ph.D., Senior Director of Biology at Sirtris, delivered a keynote address "SIRT1 Activation: A Novel Mechanism for Treating Type 2 Diabetes." Dr. Milne presented data which showed that SRT501, Sirtris' proprietary formulation of resveratrol, reduces glucose and improves insulin sensitivity in multiple pre-clinical models of Type 2 Diabetes. Dr. Milne also presented pharmacokinetic (PK) data from a Phase 1a study conducted by Sirtris in which healthy volunteers who were dosed with SRT501 had an improved exposure as compared with other published studies. Both the area under the curve concentrations (AUC) as well as the maximal concentrations (Cmax) were shown to be improved with SRT501 as compared with literature values for resveratrol. SRT501 is currently being tested in a Phase 1b study in patients with Type 2 Diabetes. Furthermore, Dr. Milne presented data with certain Sirtris proprietary novel chemical SIRT1 activators, structurally unrelated to resveratrol, which were shown to reduce glucose, improve insulin sensitivity, improve glucose tolerance, and increase the number and function of mitochondria in multiple pre-clinical models of Type 2 Diabetes. In addition, studies in a pre-clinical model demonstrate improved insulin sensitivity in muscle, liver, and fat cells. "Sirtris scientists continue to make significant progress in the development of SIRT1 activators for diseases of aging such as Type 2 Diabetes. Indeed, the new data presented today further extend Sirtris' scientific leadership in advancing sirtuin modulators as a new class of innovative therapeutics," said Christoph Westphal, M.D., Ph.D., Chief Executive Officer of Sirtris. About Sirtris Pharmaceuticals 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. Our drug candidates are designed to mimic certain beneficial health effects of calorie restriction, without requiring a change in eating habits, by activation of sirtuins, a recently discovered class of enzymes that control the aging process. The company's headquarters are in Cambridge, Massachusetts. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, the progress of pre-clinical and clinical studies of SIRT1 activators, the results of pre-clinical studies as compared with other published studies, Sirtris' position in the sirtuin field, and the potential for sirtuin modulators to receive regulatory approval. These forward-looking statements about future expectations, plans and prospects of Sirtris Pharmaceuticals involve significant risks, uncertainties and assumptions, including risks related to the lack of results that would provide a basis for predicting whether any of the Company's product candidates will be safe or effective, or receive regulatory approval, the possibility that results of pre-clinical studies are not necessarily predictive of clinical trial results, the Company's potential inability to initiate and complete pre-clinical studies and clinical trials for its product candidates, the fact that none of the Company's product candidates has received regulatory approvals, the potential inability of the Company to gain market acceptance of the Company's product candidates, and those other risks factors that can be found in the Company's filings with the Securities and Exchange Commission. Actual results may differ materially from those Sirtris Pharmaceuticals contemplated by these forward-looking statements. Sirtris Pharmaceuticals does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.