Novel Alzheimer Drug Wins FDA Fast-Track Designation
A Phase 1b/2 clinical study in patients with mild-to-moderate Alzheimer disease has been completed.
The Food and Drug Administration (FDA) has granted Fast Track status to CT1812 (Cognition Therapeutics), an investigational agent for the treatment of Alzheimer disease.
CT1812 is a first-in-class, orally-administered small molecule that targets the sigma-2 receptor complex on neuronal synapses, displacing beta amyloid oligomers from their binding sites on brain cells and clearing them into the cerebrospinal fluid. This allows synapses to regenerate and cognitive performance to return; in Alzheimer disease models, the drug has been shown to stop memory loss.
A Phase 1b/2 clinical study (COG0102) in patients with mild-to-moderate Alzheimer disease has been completed. Results from the study will be announced in a late-breaker oral presentation at the Clinical Trials on Alzheimer's Disease meeting in Boston, November 2–4, 2017.
Cogntion therapeutics receives fast track designation from US FDA for first-in-class Alzheimer's candidate, CT1812 [press release]. Pittsburgh, PA: COGRX; Published October 16, 2017. Accessed November 2, 2017.