Sirtris Announces SRT501 Lowers Glucose in Twice-Daily Dosing Clinical Trial; Study Suggests Dose Response for Proprietary Formu
April 17 2008 - 8:00AM
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. 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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