PITTSBURGH, October 16, 2017 — Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on the development of innovative therapeutics for the treatment of Alzheimer’s disease and other neurocognitive disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug CT1812 for the treatment of patients with Alzheimer’s disease.
CT1812 is a first-in-class, orally administered small molecule that has recently completed a Phase 1b/2 clinical study (COG0102) in patients with mild-to-moderate Alzheimer’s disease. CT1812 inhibits the binding of beta amyloid (Aß) oligomers to neuronal receptors and facilitates clearance of Aß oligomers into the cerebrospinal fluid. By so doing, CT1812 may decrease the toxic effects of Aß oligomers allowing synapses to regenerate and cognitive performance to return.
“There are few drugs available for the treatment of Alzheimer’s disease and none are disease modifying,” said Cognition President & CEO Kenneth I. Moch. “The number of individuals suffering from Alzheimer’s is growing dramatically, placing an ever-increasing burden on families and caregivers and on the global healthcare system. We look forward to collaborating with the FDA to advance CT1812 through clinical development to commercialization, where we hope it will significantly improve the quality of life of people living with this devastating disease.”
Fast Track designation is a process to facilitate the development and expedite the FDA review of new drugs that are intended to treat serious or life-threatening conditions and that address an unmet medical need. Early and frequent communications between the FDA and the sponsor throughout the entire drug development process help ensure that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Cognition’s lead product candidate, CT1812, has completed a Phase 1b/2 clinical study (COG0102) in patients with mild-to-moderate Alzheimer’s disease and has been granted Fast Track designation by the U.S. FDA. This highly brain penetrant compound targets the sigma-2 receptor complex on neuronal synapses, displacing toxic beta amyloid (Aß) oligomers from their binding sites on brain cells and clearing them into the cerebrospinal fluid. CT1812 has been shown in multiple Alzheimer’s disease models to stop memory loss. Results from Study COG0102 will be announced in a late-breaker oral presentation at the CTAD (Clinical Trials on Alzheimer’s disease) meeting in Boston taking place November 2-4, 2017.
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a privately held biopharmaceutical company developing a pipeline of disease modifying small molecule drug candidates to treat neurocognitive disorders. Cognition’s lead candidate, CT1812, is a proprietary first-in-class, orally available small molecule in development for the treatment of mild-to-moderate Alzheimer’s disease. CT1812 and Cognition’s other pipeline candidates were identified using the company’s disease-relevant screening and novel chemistry platforms. Additional information about Cognition and its product candidates may be found online at https://cogrx.com.