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Metabasis Therapeutics Announces Positive Results
in the Phase 2a Clinical Trial for MB07803, Its Product Candidate for
the Treatment of Type 2 Diabetes
SAN DIEGO -- April 28, 2008--Metabasis
Therapeutics announced today that MB07803 met its primary efficacy endpoint
with results demonstrating a statistically and clinically significant
reduction in fasting plasma glucose (FPG) at day 28 in its Phase 2a clinical
trial. The study also showed that MB07803 was safe and well tolerated.
MB07803 is Metabasis' product candidate for the treatment of type 2 diabetes
that acts by inhibiting fructose-1,6-bisphosphatase (FBPase).
This 28-day proof-of-concept clinical trial was a randomized, double-blind,
placebo-controlled trial involving 105 patients with type 2 diabetes with
a mean baseline fasting plasma glucose of 187 mg/dL and mean baseline
HbA1c of 8.2%. Patients received either placebo or MB07803 at an oral
dose of 10, 50, 100 or 200 mg once daily. The primary efficacy endpoint
of the study was change in FPG at day 28 from baseline.
The primary efficacy endpoint of the trial was achieved with MB07803 administered
at 200 mg once a day resulting in a statistically and clinically significant
reduction in FPG at day 28 versus placebo (p=0.0177). This clinical trial
showed that MB07803 was safe and well tolerated with 94% of the patients
completing the study and no patients withdrawing due to drug-related adverse
events. The overall adverse event profile was similar to that of the placebo.
Fasting lactate levels were within the normal range and no patients experienced
hyperlacticemia (a sustained lactate elevation above 4.5 mM). The Company
plans to present full clinical trial results at a major international
scientific conference later this year.
MB07803 is Metabasis' second-generation product candidate for the treatment
of type 2 diabetes and part of a new class of drugs that the Company discovered
internally using its NuMimetic(TM) technology. MB07803 regulates excess
glucose production in the liver by inhibiting the enzyme, FBPase, a key
component in the gluconeogenesis pathway. Excess hepatic glucose production
is believed to be a major contributing factor to the elevated glucose
levels associated with increased morbidity and mortality in patients with
type 2 diabetes.
"The results of this study provide, for the first time, evidence
that MB07803 lowers fasting plasma glucose levels in patients with type
2 diabetes," said Howard Foyt, M.D., Ph.D., FACP, vice president
of clinical development. "Achievement of a statistically significant
and clinically meaningful reduction in fasting plasma glucose levels in
this patient population with once-a-day dosing of MB07803, coupled with
demonstration of a safety and tolerability profile similar to placebo-treated
patients, is a significant step forward for our FBPase inhibitor program.
MB07803 was designed to have superior properties as compared to the first
generation FBPase inhibitor and these early results suggest that we are
on the right track. Although it is early in development and this study
was not designed to compare the efficacy with other approaches, the results
appear to be very promising and suggest that the FBPase approach may have
the potential to achieve efficacy in line with current marketed therapies."
Paul Laikind, Ph.D., president and chief executive officer, stated, "We
are very pleased with the results announced today. Not only does this
represent an important milestone for the FBPase program, it is an important
step forward in the strategic plan we outlined last year. We expect additional
important key milestones over the course of the year including the presentation
of the full data from this clinical trial, safety and efficacy data on
our novel treatment for hyperlipidemia, MB07811, recommendation of one
or more new metabolic disease therapies for clinical development and establishment
of important strategic relationships to help insure the successful and
timely development of our core and non-core assets. The results we announced
today should assist us in establishing a collaboration for MB07803 with
a strong partner thereby bolstering our efforts to develop an important
new therapy for the millions of patients suffering with type 2 diabetes."
About Type 2 Diabetes:
Diabetes is a rapidly growing, worldwide health crisis. According to the
International Diabetes Federation, in 2007, the number of patients suffering
with diabetes worldwide reached over 245 million, with treatment and prevention
costs reaching approximately $232 billion. Approximately 90% of patients
with diabetes worldwide have type 2 diabetes. According to the American
Diabetes Association, diabetes is the fastest growing disease in the U.S.
In 2007, approximately 20 million Americans, or 7% of the U.S. population,
were afflicted with diabetes, with costs associated with the disease reaching
$174 billion.
Reminder: The Metabasis management team will host a conference call and
live webcast to discuss first quarter 2008 financial results and Company
updates at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on Thursday,
May 1. Individuals interested in participating in the call may do so by
dialing 800-322-2803 for domestic callers and 617-614-4925 for international
callers. Please specify to the operator "Metabasis Therapeutics"
when asked for a passcode. The conference call will be webcast live on
Metabasis' website at www.mbasis.com under the "Investors" section,
and will be archived there for 30 days following the call. Please connect
to Metabasis' website several minutes prior to the start of the conference
call to ensure adequate time for any software download that may be necessary.
About Metabasis (www.mbasis.com):
Metabasis is a biopharmaceutical company using its proprietary technologies,
scientific expertise and unique capabilities for targeting the liver and
liver pathways. The Company has established a broad pipeline of product
candidates and advanced research programs targeting large markets with
significant unmet needs. Metabasis' core area of focus is on the discovery
and development of drug candidates to treat metabolic diseases such as
hyperlipidemia and diabetes, among others. Although not a core focus of
the Company, Metabasis has also discovered and developed drug candidates
indicated for the treatment of liver diseases such as hepatitis and primary
liver cancer, which it now intends to license or partner. All product
candidates were developed internally using proprietary technologies.
Forward-Looking Statements:
Statements in this press release that are not strictly historical in nature
constitute "forward-looking statements." Such statements include,
but are not limited to, references to Metabasis' progress on its strategic
goals and pursuit of its corporate objectives; the initiation, progress,
completion and results of clinical trials for Metabasis' product candidates,
including the expected results of clinical trials for MB07803 and MB07811;
the potential efficacy and benefits of, and the potential market for,
MB07803; the progress of Metabasis' discovery programs, including the
expected advancement of certain programs into clinical development; potential
collaborations for MB07803 and the establishment of other important strategic
relationships; and other potentially value driving future milestones and
events. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause Metabasis' actual results
to be materially different from historical results or from any results
expressed or implied by such forward-looking statements. These factors
include, but are not limited to, risks and uncertainties related to the
progress and timing of clinical trials for Metabasis' product candidates;
the fact that positive results from preclinical studies and early clinical
trials does not necessarily mean later clinical trials will succeed; difficulties
or delays in development, testing, obtaining regulatory approval, producing
and marketing Metabasis' product candidates; serious adverse side effects
or inadequate efficacy of, or serious adverse events related to, Metabasis'
product candidates or proprietary technologies; the risk that Metabasis
will not be able to build more value or retain rights for direct commercialization
of its product candidates; Metabasis' dependence on its licensees and
collaborators for the clinical development and registration of, as well
as information relating to, certain of its product candidates; potential
conflicts with collaborators that could delay or prevent the development
or commercialization of Metabasis' product candidates; the scope and validity
of intellectual property protection for Metabasis' product candidates,
proprietary technologies and their uses; competition from other pharmaceutical
or biotechnology companies; Metabasis' ability to obtain additional financing
to support its operations; and other factors discussed in the "Risk
Factors" section of Metabasis' Annual Report on Form 10-K for the
fiscal year ended December 31, 2007 and in Metabasis' other filings with
the Securities and Exchange Commission. All forward-looking statements
are qualified in their entirety by this cautionary statement. Metabasis
is providing this information as of the date of this release and does
not undertake any obligation to update any forward-looking statements
contained in this release as a result of new information, future events
or otherwise.
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