Cognosci, Inc.
Cognosci, Inc.
IND-enabling Safety and Toxicity Studies on COG1410, an Apolipoprotein-E-based Therapeutic for Alzheimer's Disease
(300 WORDS MAX.) Alzheimer's disease (AD) is the leading cause of dementia affecting 5.4 million Americans and their 12 million caregivers. Medicare and Medicaid spend about 20% of their combined programs, a total of $148 Billion/year, to evaluate and care for AD patients in mostly nursing home settings. There are no current drugs that stop or reverse the progression of AD, which typically runs a 10 to 20 year time course of increasing dementia, loss of independence, loss of learning and memory abilities and loss of life. To address this growing unmet medical need, Cognosci has focused on therapies that oppose Apolipoprotein-E4, the second best known risk factor (after age) that affects more than half of all AD patients. We have developed COG1410, a small peptide mimetic of Apolipoprotein-E3 that displays potent neuroprotective and anti-inflammatory activity in the brain. To understand the utility of COG1410 in AD, we present early studies where subcutaneous (under the skin) administration of COG1410 in animal models of AD resulted in a significant improvement of learning and memory skills together with marked decreases of microscopic brain pathology that defines AD. COG1410's activities have been cross-validated in animal models of Traumatic Brain Injury, stroke, intracranial hemorrhage and others. We are proposing to perform the first part of safety and toxicity studies of COG1410 given to rats to partially satisfy the requirements of an Investigational New Drug (IND) application that must be reviewed and approved by the Food and Drug Administration before human clinical trials can begin. In future applications, we will address the much more costly studies of COG1410 given to dogs, which together with safety studies we have already performed, will constitute a complete IND package. Once the IND for subcutaneous administration of COG1410 is approved, then human clinical trials for an Alzheimer's indication may commence.