>>TOKYO, and SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Sankyo Co., Ltd. and Metabasis Therapeutics, Inc. (Nasdaq: MBRX - News) today announced the recent initiation of a Phase IIb clinical trial of CS-917 in patients with type 2 diabetes. Sankyo licensed CS-917 from Metabasis and is responsible for the global development of the compound.
The randomized, placebo controlled, double blind Phase IIb study is designed to evaluate the effectiveness of CS-917 in lowering blood glucose levels in patients with type 2 diabetes. Efficacy of CS-917 will be evaluated by measuring levels of hemogloblin A1c (HbA1c), an accurate long-term index of a patient's average blood glucose control. Results of the Phase IIb study will be used to select the appropriate dosage of CS-917 for use in Phase III clinical trials.
"With the number of diabetes cases rising worldwide, it has never been more important to find new ways to help patients control their blood glucose levels," said Tomas Bocanegra, M.D., Vice President of Clinical Development at Sankyo's U.S. subsidiary, Sankyo Pharma Inc. "We hope to provide a new, important treatment option for the millions of patients affected by type 2 diabetes."
CS-917, the first in a new class of investigational drugs called fructose 1-6 bisphosphatase inhibitors (FBPase), appears to inhibit a metabolic pathway in the liver called gluconeogenesis, which is responsible for the excessive production of glucose by patients with type 2 diabetes. Previous Phase IIa studies have demonstrated promising results in lowering blood glucose levels.
"We are very pleased with the progress we are making with CS-917," said Dr. Paul Laikind, Chairman, CEO and President of Metabasis. "Two previously completed studies provided important proof of concept for the program and the study now underway, if successful, will allow us to move the compound into Phase III trials."
According to the American Diabetes Association (ADA), approximately 18.2 million people have diabetes, with 90 to 95 percent affected by type 2 diabetes, a disorder in which the cells do not use insulin properly. The number of new cases of diabetes also is rising rapidly. The World Health Organization (WHO) estimates that at least 171 million people worldwide have diabetes, and that this figure is likely to double by 2030 to reach 366 million.
About Sankyo
Sankyo Co., Ltd. of Tokyo, one of Japan's largest pharmaceutical companies, has a long history of discovering new classes of drugs, including the statin class of lipid-lowering drugs. Beginning with its discovery of the first statin, mevastatin, and the co-discovery of lovastatin, the first statin to be marketed, Sankyo has been a pioneer in the cardiovascular disease arena. Additionally, Sankyo discovered, developed, manufactures and markets pravastatin sodium and olmesartan medoximil, an angiotensin II receptor blocker (ARB). Sankyo also developed and launched the first glitazone, which revolutionized long-term control of type 2 diabetes, and has a number of other potentially promising compounds in the diabetes arena. Sankyo's early stage pipeline focuses on oral therapies to satisfy key unmet needs in six major fields -- cardiovascular disease, metabolic disease, respiratory and immune disease, bone and joint disease, infectious disease, and oncology. For further information about Sankyo and its products, log on to sankyo.co.jp.
About Metabasis (www.mbasis.com):
Metabasis Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs principally to treat metabolic diseases linked to pathways in the liver and to treat liver diseases. The company has established a broad product pipeline targeting large markets with significant unmet medical needs. Metabasis has three internally discovered, novel product candidates in clinical development: CS-917, remofovir and MB07133, indicated for the treatment of type 2 diabetes, hepatitis B and primary liver cancer, respectively. All three products are being studied in patients and preliminary evidence of efficacy has been demonstrated with CS-917 and remofovir. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) technology and the HepDirect(TM) technology. The NuMimetic technology was used to discover CS-917, a first-in-class gluconeogenesis inhibitor, and was also used to identify MB07803, a 2nd generation gluconeogenesis inhibitor that is expected to enter the clinic in 2005 for the treatment of type 2 diabetes. The HepDirect technology, a liver-targeting prodrug technology, was used to develop remofovir and MB07133 and is also being used in a partnership with Merck to discover new treatments for hepatitis C. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and know-how.<<
snip
I would assume, but do not know, that this would trigger a milestone payment. These guys might have a reasonably newsy '05? A few things coming out of the pipe, anyhow. Might be worth a deeper look, as it doesn't look too expensive, first blush. Anybody got a head start?
Cheers, Tuck |
