Sirtris Announces Positive Results with Proprietary Version of Resveratrol, SRT501, in a Phase 1b Type 2 Diabetes Clinical Study
08 January 2008 - 8:30AM
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 na�ve 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.� 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 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.
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