— Elayta Crossed Blood Brain Barrier and Reached CNS Levels Associated in Preclinical Studies with Cognitive Improvement —
Pittsburgh, Feb. 19, 2019 — Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on the protection and restoration of synaptic function in neurodegenerative disorders, announced today the publication of clinical data from the Company’s Phase 1 trial of Elayta™ (CT1812) in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.
Top-line findings from this two-part randomized, double-blind, placebo-controlled Phase 1 study had previously been reported as part of a “Late Breaker” Oral Presentation at the 9th Annual Clinical Trials on Alzheimer’s Disease (CTAD) meeting. Results showed that Elayta was well tolerated by the 93 study participants, with mild headache and GI disturbances representing the most commonly observed adverse events. At peak plasma concentrations, dose-dependent increases in cerebrospinal fluid (CSF) levels of Elayta were measured, confirming that Elayta crossed the blood-brain barrier. No differences in plasma levels of Elayta were detected between cohorts of patients who were fed versus those who had fasted.
Cognition’s co-founder, Chief Science Officer Susan Catalano, Ph.D., stated, “The pharmacokinetic results from this Phase 1 study showed that the CSF concentrations of Elayta observed following once-daily doses exceeded the expected minimum concentration required to improve learning and memory in mice, and were well tolerated at these doses. This finding gives us cause for optimism that in longer Phase 2 trials, such as the ongoing SPARC and SHINE trials, Elayta has the potential to demonstrate a positive effect on learning and memory in Alzheimer’s disease patients.”
The article details are as follows: Grundman M, Morgan R, Lickliter JD, Schneider LS, DeKosky S, Izzo NJ, Guttendorf R, Higgin M, Pribyl J, Mozzoni K, Safferstein H, Catalano SM. A Phase 1 Clinical Trial of the Sigma-2 Receptor Complex Allosteric Antagonist CT1812, a Novel Therapeutic Candidate for Alzheimer’s Disease. Alzheimers & Dementia. 2019 Jan 23;5:20-26.
About the Phase 1 Study
The Phase 1 study summarized in this paper was a two-part randomized, double-blind, placebo-controlled clinical trial. In Part A, 54 healthy adults aged 18-65 were given a single dose of Elayta or placebo. In Part B, 39 healthy adults aged 18-65 and nine aged >65 received Elayta or placebo once daily for 14 days. Safety and tolerability were the primary endpoint; plasma pharmacokinetics were secondary endpoints.
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a privately held biopharmaceutical company developing proprietary small-molecule therapeutics to treat neurodegenerative diseases caused by membrane trafficking dysfunction. Cognition’s drug candidates may halt the progression of Alzheimer’s disease, Parkinson’s disease and other disorders that occur when toxic oligomeric proteins interrupt critical cellular pathways in the brain.
Cognition’s lead candidate, Elayta™, is a novel first-in-class, orally available small molecule that in initial clinical studies has shown the potential to normalize protein trafficking and lipid metabolism pathways that are disrupted in Alzheimer’s disease and allow the protection and restoration of synapses. Elayta is currently being tested for the treatment of mild-to-moderate Alzheimer’s disease in three Phase 2 clinical studies: SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition), SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients) and SHINE (Synaptic Health and Improvement of Neurological Function with Elayta). These studies are supported by grants (award numbers RF1AG057780, RF1AG057553 and R01AG058660) from the National Institute on Aging of the NIH. Elayta has been granted Fast Track designation by the U.S. FDA.
Elayta 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 http://www.cogrx.com.
This press release contains “forward-looking statements” concerning the development and commercialization of Cognition’s products, the potential benefits and attributes of such products, and Cognition’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Cognition undertakes no obligation to update any forward-looking statements for any reason.