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Metabasis is a biopharmaceutical company focused on
the discovery, development and commercialization of novel drugs
by applying 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' product pipeline represents candidates indicated
for the treatment of metabolic diseases such as hyperlipidemia and
diabetes, among others. Additionally, our pipeline includes drug
candidates for the treatment of liver diseases such as hepatitis
and primary liver cancer which the company plans to license to companies
focused on these areas. All of our product candidates were developed
internally using proprietary technologies including our NuMimetic
and HepDirect technologies.
Core Metabolic Disease Product Pipeline:
Metabolic Diseases
We have two product candidates in our core metabolic product pipeline,
MB07811, a novel therapy currently being studied for the treatment
of hyperlipidemia and MB07803, a novel product candidate for the
treatment of type 2 diabetes. Additionally, we have several discovery
programs targeting metabolic diseases, the most advanced being glucagon,
TR beta agonist and AMPK. While there are drugs available to treat
these diseases, there is tremendous need and opportunity for new
therapies for cholesterol disease and diabetes as most patients
are inadequately treated or controlled. We believe these and other
metabolic diseases may be treated by targeting metabolic pathways
that reside in the liver, such as pathways responsible for the production
of glucose, cholesterol and fat molecules.
MB07811, a product candidate for the treatment of hyperlipidemia,
is the first of a new class of compounds designed to lower serum
cholesterol, reduce serum triglyceride (TG) levels and liver fat
and reduce lipoprotein (a) [Lp(a)] through a liver targeted approach.
We successfully completed a 14-day, Phase 1b clinical trial for
MB07811 in the second quarter of 2008, which showed the compound
to be safe and well tolerated across all seven dose cohorts tested.
Additionally, statistically and clinically significant reductions
in LDL-cholesterol and fasting TG levels were observed. We retain
exclusive worldwide commercialization rights to MB07811.
MB07803, for the treatment of type 2 diabetes, is a second
generation product candidate in our fructose-1,6-bisphosphatase
(FBPase) inhibitor class, a novel class of drugs discovered internally
by Metabasis using our NuMimetic technology. MB07803 represents
a new and a novel mechanism of action that we believe could be an
important new approach for treating poorly controlled patients.
In the second quarter of 2008, we successfully completed a Phase
2a, 28-day, proof-of-concept clinical trial for MB07803 and announced
top-line results. MB07803 met its efficacy endpoint with results
demonstrating a statistically and clinically significant reduction
in fasting plasma glucose (FPG) at day 28 versus placebo, and was
shown to be safe and well tolerated. MB07803 has been shown in multiple
preclinical studies and Phase 1 clinical trials to have an improved
pharmacokinetic profile as compared to a first generation compound
that was studied previously. Metabasis is independently developing
this important product candidate and we retain commercialization
rights.
Glucagon is an advanced research program focused on identifying
chemically novel, potent, orally bioavailable glucagon antagonists
for treating type 2 diabetes. Our most advanced compound has shown
significant and consistent lowering of blood glucose when dosed
orally to diabetic db/db mice and three other animal models of diabetes
or insulin resistance. We hope to recommend the most advanced compound
in this class for clinical development by mid 2008.
TR beta Agonist is an advanced research program is to identify
second-generation TR beta agonists for managing hyperlipidemia.
This program may yield additional development candidates that lower
cholesterol and triglycerides by the same mechanism as MB07811 but
with potential improvements. We hope to recommend the most advanced
compound from the program for clinical development by mid 2008.
AMPK is a program in collaboration with Merck seeking treatments
for metabolic diseases such as hyperlipidemia, type 2 diabetes and
a disease associated with fatty liver known as non-alcoholic steatohepatitis,
by identifying small molecule activators of AMP-activated protein
kinase to inhibit cholesterol and lipid production in the liver.
The three-year research term of this collaboration has been extended
by one year through June 2009.
Non-Core Liver Disease Product Pipeline:
Liver Diseases
Additionally, we have two product candidates in our non-core liver
product pipeline, MB07133 for the treatment of primary liver cancer
and pradefovir, for the treatment of hepatitis B, both of which
we plan to license to companies focused on these areas. Our most
advanced discovery program targeting liver disease is HCV.
MB07133, developed using our HepDirect technology, is a product
candidate for the treatment of primary liver cancer. A Phase 1/2
clinical trial was completed in June 2007. We expect to review data
from the Phase 1/2 clinical trial and plans for our next clinical
trial with the regulatory authorities in 2008, positioning the candidate
for initiation of the next clinical trial in the second half of
2008. We retain exclusive worldwide commercialization rights to
MB07133, but plan to license MB07133 to a suitable company for the
development and commercialization of this product candidate.
Pradefovir is a product candidate for the treatment of hepatitis
B. A Phase 2b clinical trial for pradefovir was completed in 2006.
Metabasis recently regained exclusive development and commercialization
control of pradefovir. We are reviewing plans for the next step
for this product candidate which will likely include licensing pradefovir
to a suitable company for the development and commercialization
of this product candidate
HCV is a program in collaboration with Merck to apply our
HepDirect technology to certain compounds Merck has studied for
the treatment of hepatitis C infections.
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Metabasis began operation with an experienced
team of talented scientists and associates who had successfully worked
together for years. |
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