Cheers!
A
CAMBRIDGE, Mass., Jan 07, 2008 (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, announced today that the Company's first product to enter the clinic,
SRT501, was found to be safe and well-tolerated, and was found 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. These data were
presented at the 26th Annual JPMorgan Healthcare Conference on Monday, January
7th 2008 at 1:30 pm PST in San Francisco.
This 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 were naive to other diabetes drug
treatments. 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, suggesting no drug accumulation. There were no serious adverse
events and no dose-related adverse events. Importantly, 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.
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 which control the aging
process. Specifically, SRT501 acts by increasing mitochondrial activity and
therefore is targeted to address metabolic diseases, such as Type 2 Diabetes.
"This is the first time that a small molecule targeting sirtuins, the genes
which control the aging process, has shown efficacy in a disease of aging," said
Peter Elliott, Ph.D., Senior Vice President of Development at Sirtris. "These
Phase 1b study results are an important step forward for Sirtris because they
represent significant progress in our clinical development of sirtuin
therapeutics. We are very pleased to see the safety profile observed in
preclinical studies translate into a well-tolerated drug molecule in patients,
and we are very encouraged by the glucose lowering effects measured in the oral
glucose test."
Christoph Westphal, M.D., Ph.D., CEO and Vice Chair of Sirtris added, "Effective
treatment for Type 2 Diabetes, a disease of aging, is an unmet medical need and
sirtuin therapeutics may offer significant potential. SRT501 may represent a
promising treatment option for these 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."