Metabasis starts phase 1 trial of potential new diabetes treatment

By E. Janene Geiss

Philadelphia, Feb. 14 - Metabasis Therapeutics, Inc. said Tuesday that it has begun a phase 1 human clinical trial of MB07803, a potential treatment for patients with type 2 diabetes.

MB07803 is the second of a new class of drugs discovered by Metabasis that regulates glucose production in the liver by inhibiting an enzyme known as fructose 1,6 bisphosphatase (FBPase), a key component of the pathway responsible for the production of glucose known as the gluconeogenesis pathway, according to a company news release.

Metabasis retains all development and marketing rights to MB07803, officials said.

The first drug candidate in this class, CS-917, also discovered by Metabasis, is being developed in collaboration with Sankyo Co., Ltd. and has shown promise as a treatment for diabetes in preclinical and early clinical studies, officials said.

Currently, the safety and efficacy of CS-917 are being studied in a multi-center, double-blind, placebo-controlled phase 2b clinical trial, officials said. Sankyo funds and directs the clinical development of CS-917.

Targeting FBPase represents a new therapeutic approach, discovered by Metabasis, designed to potently and selectively control liver glucose production by specifically inhibiting the gluconeogenesis pathway.

An over-active gluconeogenesis pathway is responsible for the abnormal overproduction of glucose in the liver of patients with type 2 diabetes, officials said.

By specifically inhibiting gluconeogenesis, liver glucose production should be reduced and blood glucose levels decreased, officials said.

Patients with type 2 diabetes have chronically elevated blood sugar levels and consequently often suffer from severe complications, including heart disease, stroke, blindness, peripheral vascular disease, kidney disease and death.

Normalizing elevated glucose in diabetic patients remains the goal for diabetes drug therapy since the currently available therapies only achieve modest glucose lowering for the majority of patients.

While MB07803 is structurally different from the first generation compound and was designed to have certain pharmacological advantages over CS-917, both compounds are designed to inhibit gluconeogenesis by targeting FBPase.

In two previously completed phase 2a clinical trials involving a total of 185 patients with type 2 diabetes, treatment with CS-917 resulted in clinically and statistically significant reductions in blood glucose levels, officials said.

Metabasis said it believes that if the promise of this potential new class of drugs is realized upon further clinical evaluation and both products are ultimately approved for use, both could find wide usage.

If successfully developed, these drug candidates are expected to be used alone or in combination with certain other diabetes therapies that target the removal of glucose from the blood, the company said.

"We are very excited about the potential of FBPase inhibition as a new approach for treating type 2 diabetes. Diabetes is a major medical problem throughout the world with devastating and costly consequences. If approved for use, CS-917 and MB07803 used alone or in combination with other drugs could prove to be important new therapies for combating this widespread disease," Mark Erion, Metabasis' chief scientific officer and executive vice president of research and development, said in the release.

MB07803 is the company's fourth internally discovered product candidate to enter clinical development, officials said. It also is the first of two clinical introductions planned for 2006. The second is a first-in-class clinical candidate, MB07811, which has the potential to be a new treatment for reducing serum cholesterol, officials said.

Metabasis is a San Diego biopharmaceutical company focused on development and commercialization of novel drugs to address some of the world's most widespread and costly chronic diseases involving pathways in the liver.

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