SRT501, the first SIRT1 activator to enter the clinic, shows safety, trends in lowering fasting plasma glucose, and a significant lowering of glucose in an oral glucose tolerance test as presented at the 26th Annual JPMorgan Healthcare Conference, January 7th 2008
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
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."
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
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 potential therapeutic
effects of SIRT1 activators including SRT501 for diseases of aging,
such as Type 2 Diabetes, the progress and results of pre-clinical and
clinical studies of SIRT1 activators, the potential therapeutic
effects of SRT501 and other SIRT1 activators, and the potential of
sirtuin modulators and activators 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.
SOURCE: Sirtris Pharmaceuticals, Inc.
Sirtris Pharmaceuticals, Inc.
Michelle Dipp, M.D., Ph.D., 617-252-6920
Senior Director of Corporate Development
Sirtris Pharmaceuticals, Inc.
John Lacey, 781-354-7452
Assoc Dir. Corp Communications
For Sirtris Pharmaceuticals, Inc.
Sheryl Seapy, 949-608-0841