Metabasis' Results From Its Phase 2a Clinical Trial For MB07803 For Diabetes Type 2 To Be Presented At World Congress
As reported in April, Metabasis successfully completed a Phase 2a, 28-day initial proof-of-concept clinical trial for MB07803, its second-generation FBPase inhibitor product candidate for the treatment of type 2 diabetes. The primary efficacy endpoint of the clinical trial was achieved with administration of MB07803 once daily, resulting in a statistically and clinically significant reduction in fasting plasma glucose (FPG) at day 28 versus placebo (p=0.0177). The clinical trial also showed that MB07803 was safe and well tolerated. The overall adverse event profile was similar to that of placebo. Fasting lactate levels were within the normal range, and no patients experienced hyperlacticemia (a sustained lactate elevation above 4.5 mM).
Alan J. Garber, M.D., Ph.D., will give the presentation, entitled, "Phase 2a Efficacy, Safety and Tolerability Study of MB07803, A Second-Generation Fructose-1,6-Bisphosphatase Inhibitor, in Patients with Type 2 Diabetes Mellitus (T2DM)." Dr. Garber serves as Professor in the Departments of Medicine, Biochemistry and Molecular Biology, and Molecular Cellular Biology, at Baylor College of Medicine in Houston, Texas. He also serves as an Attending Physician at the Methodist Hospital and Ben Taub General Hospital, both in Houston, Texas. Dr. Garber was the Chair of the Council on Complications for the American Diabetes Association and chairman of numerous task forces and consensus development committees related to the field of diabetes and its complications. He has authored approximately 200 peer-reviewed publications, as well as book chapters and monographs on diabetes, its complications and related disorders. He has been intimately involved in clinical research throughout his career, notably with metformin and more recently with vildagliptin.
"The results of this Phase 2a clinical trial are very encouraging, and support the continued development of MB07803 as an important new therapy for treating type 2 diabetes," commented Dr. Howard Foyt, M.D., Ph.D., FACP, vice president of clinical development. "CODHy provides an excellent opportunity to present these results to the scientific community. We are pleased to have an individual of Dr. Alan Garber's stature presenting these data. Dr. Garber, who was a principal investigator on this clinical trial, is a leader in diabetes clinical research and is well recognized for his clinical trial work on metformin, as well as other diabetes drugs and for his specialized knowledge and experience in the areas of metabolic disease and diabetes. With respect to next steps for MB07803, based on the excellent safety profile observed in the successful Phase 2a trial, we are planning to evaluate higher doses in patients later this year with the aim of using the results of this trial to select doses for the Phase 2b clinical trial that we expect will begin in 2009."
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.
About Metabasis
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.
Metabasis
Metabasis "Rezultatele de la faza a 2a studiu clinic pentru MB07803 pentru diabet zaharat de tip 2 sã fie prezentatã la Congresul Mondial - Metabasis' Results From Its Phase 2a Clinical Trial For MB07803 For Diabetes Type 2 To Be Presented At World Congress - articole medicale engleza - startsanatate