April 4, 2003
Metabasis Therapeutics, Inc. Announces the Commencement of Clinical
Testing of Hepavir B in Patients With Hepatitis B
[PR Newswire]
PR via NewsEdge Corporation : SAN DIEGO, April 3 /PRNewswire/ --
Metabasis Therapeutics, Inc. (Metabasis) announced today that Ribapharm,
Inc., (Ribapharm) has begun clinical testing of Hepavir B, an orally
active,
liver-specific prodrug of the proven antiviral agent adefovir. Hepavir B
was
developed by Metabasis and licensed to Ribapharm in October 2001.
Ribapharm filed an IND in October 2002, which was subsequently allowed
by the United States Food and Drug Administration.
Hepavir B was developed using Metabasis proprietary HepDirect(tm)
Technology, a broadly applicable prodrug technology that results in the
production of the active drug specifically in the liver. By enabling
higher
drug concentrations in the liver and minimizing exposure to non-liver
tissues, HepDirect prodrugs may improve efficacy, reduce toxicity and
thus
improve the treatment of liver and liver-related diseases. Adefovir, the
active ingredient of Hepavir B, has proven to be an effective drug for
the
treatment of patients with chronic hepatitis B. However, studies have
shown
that accumulation of the drug in the kidney results in dose limiting
renal
toxicity. The HepDirect Technology is designed to change the bio-distribution
of the active form of adefovir and thereby result in an improved
therapy. Preclinical studies show that the HepDirect prodrug of adefovir,
Hepavir B, achieves significantly higher levels of the active form in
the liver and lower levels in the kidney resulting in an overall 10- to
50-fold increase in liver targeting. Metabasis believes that this
redistribution of the drug will allow for more optimal dosing and
therefore a more efficacious drug with improved safety.
Dr. Paul Laikind, Chairman, President and CEO of Metabasis stated,
"We are
very pleased with the progress made in the development of Hepavir B.
Ribapharm previously announced that it had successfully completed a
Phase 1 trial with the drug. This was important both for the continued
development of Hepavir B but also because it marked the first clinical
experience with our liver-specific pro-drug technology, HepDirect. The
recent initiation of studies in patients infected with the hepatitis B
virus marks another important milestone in the development of the drug.
Dr. Mark Erion, Executive Vice President of Research and Development
said, "The success to date with Hepavir B further demonstrates the
potential of the HepDirect Technology for developing new and improved
drugs for the treatment of liver and liver-related diseases. Based on
the preclinical experience, the high liver specificity provided by the
HepDirect Technology should minimize systemic exposure and lead to an
overall improvement in the therapeutic index of the drug. The second
HepDirect prodrug to be recommended for development is MB7133, a
HepDirect oncolytic for treating primary liver cancer. If all goes
according to plan we will begin clinical testing of MB7133 next quarter
in the United States and Asia. There are currently no approved drugs for
the treatment of primary liver cancer. Our pre-clinical results with
MB7133 combined with the early data from the Hepavir B clinical trials
increases our confidence in the potential of MB7133 to successfully
treat this deadly disease."
Dr. Laikind added, "We continue to execute our business model of
discovering exciting new drugs to treat important, often deadly diseases
and steadily advancing these products through clinical development. When
MB7133 enters the clinic next quarter Metabasis will have three products
at various stages of clinical development. In addition to Hepavir B and
MB7133, our drug for type 2 diabetes, CS-917, a novel gluconeogenesis
inhibitor, is being evaluated in phase 2 clinical trials in the United
States." Metabasis' partner on that project, Sankyo Co., Ltd, has
primary responsibility for developing CS-917.
Metabasis Therapeutics, Inc. ( www.mbasis.com
) is a privately held,
biopharmaceutical company that develops proprietary products for the
treatment of human disease with a current focus on liver and
liver-related
diseases. The Company employs various resources for discovering and
perfecting new products, is a leader in the field of
nucleoside/nucleotide
chemistry and metabolism, and has proprietary expertise in liver biology
and liver-specific drug delivery. Metabasis has discovered and developed
a new class of drugs for treating diabetes that act to lower liver
glucose
production in diabetic patients. The first drug from this program,
CS-917,
is being developed in collaboration with Sankyo Co., Ltd. and is
currently
undergoing clinical testing. The Company has also developed the
HepDirect
Prodrug Technology that allows liver-specific delivery of new and
existing
drugs. Two drugs derived from the HepDirect Technology are in
development; a drug for hepatitis B called Hepavir B and a drug for
primary liver cancer called MB7133. Hepavir B is the subject of a
partnership with Ribapharm, Inc. and is currently being evaluated in
patient trials. The drug for primary liver cancer is expected to enter
the clinic during the second quarter of 2003. The Company has
approximately 80 employees and occupies state-of-the-art research
facilities in San Diego, California.
SOURCE Metabasis Therapeutics, Inc. -0- 04/03/2003
/CONTACT: Paul Laikind, Ph.D. of Metabasis Therapeutics, Inc.,
+1-858-622-5550/
/Web site: http://www.mbasis.com /
CO: Metabasis Therapeutics, Inc.; Sankyo Co., Ltd; Ribapharm, Inc.
ST: California
IN: HEA MTC BIO
SU: SVY
ES
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