TransTech And FDA Agree On Special Phase 3 Trial For Alzheimer's Drug
Clinical stage pharmaceutical firm TransTech Pharma announced that it has come to an agreement with the U.S. Food and Drug Administration (FDA) Division of Neurology Products on a special protocol assessment regarding the Phase III trial of its investigational drug TTP488 for mild Alzheimer’s disease.
TTP488 is a novel, small-molecule, orally active antagonist of Receptor for Advanced Glycation Endproducts (RAGE). RAGE is implicated in the pathogenesis of Alzheimer’s disease. Data suggest that sustained Ab interaction with RAGE at the blood-brain barrier is a critical component of amyloid plaque buildup and associated chronic neural dysfunction in AD patients. TTP488 slowed cognitive decline in patients with mild to moderate Alzheimer’s disease, exhibiting increased efficacy in patients with milder forms of AD.
Special Protocol Assessment is a binding agreement stating that the design, planned execution, and statistical analyses of a Phase III trial are satisfactory to form the basis of an FDA approval. Steve Holcombe, President and CFO of TransTech Pharma, said, “The agreement on the SPA represents a significant milestone for the development of TTP488 and for TransTech Pharma. We are extremely pleased to receive agreement on the SPA and to have a clear path forward for the submission and regulatory approval of TTP488 for the treatment of patients with mild Alzheimer’s disease.” AD is currently the 6th leading cause of death in the U.S. and affects over 5 million people in the country.
The FDA and the company agreed SPA Phase III trial will be a double blind, placebo controlled, randomized, multi-center study investigating the safety and efficacy of the drug in patients with mild AD. TTP488 will be directly compared to placebo over 18 months of treatment. Primary efficacy endpoint will be change in AD cognitive scale and clinical dementia rating. An estimated 800 patients will be enrolled in the trial, which is expected to begin before the end of 2014.
Following the successful Phase II trial of TTP488, TransTech submitted its Phase III trial plans to the FDA for approval last year. The agency has already designated the drug Fast Track status because of its novel approach in the treatment of AD by targeting the RAGE biochemical target.