FDA Grants TransTech Pharma Inc. Fast Track Designation for TTP488 for the Treatment of Alzheimer’s Disease

Source: PharmaManufacturing.com

Mar 20, 2013

TransTech Pharma Inc.

TransTech Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for TTP488, a new small-molecule chemical compound being developed for the treatment of Alzheimer’s disease. TTP488 prevents the interaction of amyloid beta (Aβ), a material found in the cells of Alzheimer’s patients, and a member of the immunoglobulin supergene family of molecules known as the Receptor for Advanced Glycation Endproducts (RAGE). TTP488 is the first drug related to RAGE, a relatively new biological target in Alzheimer’s disease research, with demonstrated success in multiple clinical trials. TransTech Pharma discovered, developed and owns the rights to this drug candidate.

The FDA’s Fast Track designation is granted to development products intended for the treatment of a serious or life-threatening condition that demonstrate the potential to address unmet medical needs. The Fast Track program facilitates the development and expedites the review of qualifying new drugs. Under Fast Track designation, drugs are eligible for accelerated FDA approval and are likely to be considered appropriate to receive priority during the review process.

“We are very pleased to see that TTP488 has received Fast Track designation,” said Dr. Adnan Mjalli, Chairman and Chief Executive Officer of TransTech Pharma. “This development reflects a recognition that TT488 has the potential to address huge unmet medical needs for the treatment of millions of patients suffering from Alzheimer’s disease, a devastating and life-threatening disease with profound consequences for our aging population.”

About TTP488

Substantial data suggest that RAGE is involved in the pathogenesis of Alzheimer’s disease, and that sustained Aβ interaction with RAGE at the blood-brain barrier (BBB), or in neuronal or microglial cells, is an important element of amyloid plaque formation and chronic neural dysfunction.

TTP488 is a novel, small-molecule, orally active antagonist of RAGE. In a recent double-blind clinical trial where data was taken over 18 months, TTP488 slowed cognitive decline in patients with mild to moderate Alzheimer’s disease. TransTech Pharma discovered and developed TTP488 using its proprietary drug discovery platform TTP Translational Technology.

About Alzheimer’s Disease

Alzheimer’s disease, the most common form of dementia, is a progressive neurodegenerative disorder that causes decline in cognition and functional abilities. It has been estimated to affect 5 million individuals in the United States, and represents the 6th leading cause of death. Worldwide, there are currently more than 35 million people with dementia, and the number is predicted to increase to over 115 million by 2050.

While current approved therapies for Alzheimer’s disease focus on improving the symptoms of the cognitive dysfunction, there is currently no treatment to slow disease progression.