Kalamazoo Pharma Gets Foundation Grant For Trial Of Alzheimer's Drug

Kalamazoo-based Metabolic Solutions Development Co. said Wednesday that it has received a $773,000 grant from the Alzheimer's Drug Discovery Foundation to conduct a pilot Phase 2a trial of MSDC-0160, MSDC's pioneer compound for the treatment of metabolic diseases associated with altered mitochondrial function.

"This funding from ADDF enables us to take an important step in the search for a new treatment for Alzheimer's disease," said Jerry Colca, president and chief scientific officer of MSDC. "MSDC-0160 is a novel insulin sensitizer that modulates mitochondrial metabolism.  Growing evidence suggests that loss of mitochondrial function and decline in brain glucose metabolism could be a contributing cause of Alzheimer's disease. This study will help us determine if MSDC-0160 affects glucose utilization in specific regions of the brain and determine the feasibility of conducting future large-scale clinical studies in patients with mild Alzheimer's disease."

The double-blind, placebo-controlled study will involve patients age 55-85 who have been diagnosed with mild Alzheimer's disease. Up to 50 patients will be randomized to receive either MSDC-0160 (150 mg) or placebo once daily for 90 days. The effects of MSDC-0160 on brain glucose utilization (measured by FDG-PET) and the safety profile of the compound will be analyzed in addition to global cognitive function.

The study will be performed at Rush University Medical Center in Chicago. The principal investigator is Raj C. Shah, M.D., medical director of the Rush Memory Clinic at the Rush Alzheimer's Disease Center. Analysis of brain glucose utilization will be performed in collaboration with the innovative imaging company Abiant Inc.

The current funding follows a $100,000 grant from the ADDF in 2009 that supported preclinical research, conducted in collaboration with Douglas Feinstein, Ph.D. of the Jesse Brown VA Medical Center and the University of Illinois at Chicago, which demonstrated positive effects of MSDC-0160 in a mouse model of Alzheimer's disease.

"We are very enthusiastic about MSDC's novel compound as a potential new treatment for Alzheimer's disease," said Howard Fillit, M.D., ADDF's executive director. "Our ongoing relationship with the company further reinforces the ADDF's commitment to venture philanthropy as a catalyst for the acceleration of new drugs to prevent, treat and, ultimately, cure Alzheimer's disease."

MSDC-0160 also is currently being studied in patients with type 2 diabetes. A 90-day, Phase 2b study involving approximately 330 patients at 26 sites throughout the United States was launched in September 2010.

MSDC is a drug discovery and development company exploiting novel molecular targets to develop new therapies for metabolic diseases associated with altered mitochondrial function, especially insulin resistance and type 2 diabetes. The company has raised nearly $50 million in support of the development of its pioneer and lead products, MSDC-0160 (currently in Phase 2b) and MSDC-0602 (currently in Phase 2a), which are novel insulin sensitizers that selectively modulate mitochondrial control of certain metabolic-signaling and nutrient-sensing pathways, resulting in improved insulin action without fluid retention or weight gain.

MSDC was founded in 2006 by former Upjohn Co. researchers Jerry Colca and Rolf Kletzien.

More at www.msdrx.com.