PITTSBURGH, May 22, 2018 — 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 the receipt of two multi-year grants from the National Institute on Aging (NIA) of the National Institutes of Health (NIH) totaling $6.6 million. These awards will fund two clinical studies of Elayta™ (CT1812), Cognition’s lead candidate for the treatment of mild-to-moderate Alzheimer’s disease, which are primarily designed to probe Elayta’s unique synaptoprotective mechanism of action.
Elayta has been shown in prior clinical studies to reduce the concentrations of synaptic damage proteins in the cerebrospinal fluid (CSF) of individuals with Alzheimer’s disease. These results are consistent with a positive effect on synapses, suggesting that Elayta may be able to stop the loss of synapses caused by toxic beta amyloid oligomers (AβOs) and facilitate the regeneration of synapses, thus restoring memory function.
The SNAP study (COG0104) is a target engagement study that will measure the displacement of AβOs and their clearance into the CSF after a single dose of Elayta and will be undertaken at the University of Pennsylvania. The SPARC study (COG0105) is a synaptic protection study that will compare changes in synapse density following administration of Elayta or placebo for 24 weeks and will be undertaken at the Yale Alzheimer’s Disease Research Unit. Both studies are expected to commence patient dosing in mid-2018.
“We are working with three esteemed investigators on these studies: Yvette I. Sheline, M.D. at the University of Pennsylvania for SNAP, and Christopher H. van Dyck, M.D. at the Yale Alzheimer’s Disease Research Unit and Richard E. Carson, Ph.D. at the Yale PET Center for SPARC,” stated Cognition Therapeutics co-founder and CSO Susan Catalano, Ph.D., who is principal investigator on both NIA grant awards. “Drs. Sheline, van Dyck and Carson are leaders in their fields and pioneers in neurocognitive disorder research. Their insights into Elayta’s mechanism of action have been invaluable, and we look forward to working with these experts and their colleagues to advance our understanding of Elayta and the underlying mechanisms of Alzheimer’s disease.”
Cognition President and CEO Kenneth I. Moch, concluded, “These NIA grant awards are important validation of and support for our novel scientific and clinical approach to treating Alzheimer’s disease. The Institute has been a long-time supporter of Cognition’s research efforts, without which we may not have achieved the research and development milestones that we have reached to date.”
The SNAP Study (COG0104)
The SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients) study will randomize up to 18 patients with Aβ‑positive mild-to-moderate Alzheimer’s disease to receive a single dose of either Elayta or placebo. Plasma and CSF of study participants will be sampled hourly for 24 hours via indwelling catheters. At the end of the study period, plasma and CSF concentrations of AβOs and Elayta will be assessed to determine if Elayta’s engagement with the sigma-2 receptor complex is correlated with an increased off-rate of AβOs from their binding site on neurons. Physical and cognitive changes will also be assessed at baseline and after the 24-hour study period. This study will enroll patients at the University of Pennsylvania under the direction of Yvette I. Sheline. The SNAP study is being supported by the NIA under award number RF1AG057780. More information about SNAP may be found at www.clinicaltrials.gov under trial identifier NCT03522129.
The SPARC Study (COG0105)
The SPARC (Synaptic Protection for Alzheimer’s Recovery of Cognition) study will compare changes in synaptic density in 21 Aβ-positive Alzheimer’s disease patients who will be randomized to receive treatment with one of two doses of Elayta or placebo once daily for 24 weeks. Synaptic density will be determined at baseline, 12 weeks and 24 weeks using positron emission tomography (PET) imaging with a tracer that is selective for synaptic vesicle glycoprotein 2A (SV2A), a membrane protein expressed in the majority of synapses. SPARC is world’s first study to measure longitudinal changes in synapse number using this imaging method in Alzheimer’s disease patients. Study participants will be enrolled at the Yale Alzheimer’s Disease Research Unit under the direction of Christopher van Dyck and scans will be performed at the Yale PET Center under the direction of Richard E. Carson. The SPARC study is being supported by the NIA under award number RF1AG057553. More information about SPARC may be found at www.clinicaltrials.gov under trial identifier NCT03493282
About Elayta (CT1812)
Cognition’s lead product candidate, Elayta (CT1812), is a highly brain-penetrant small molecule with a unique disease-modifying synaptoprotective mechanism of action. This orally dosed drug candidate protects synapses by selectively displacing toxic AβOs from their synaptic receptors, thus stopping downstream damage. Elayta has been shown in preclinical models of Alzheimer’s disease to restore synapse numbers and improve memory function. Consistent with these findings, Cognition’s Phase 1b/2a clinical trial demonstrated that Elayta significantly reduces concentrations of synapse damage proteins in the cerebrospinal fluid of Alzheimer’s patients. Elayta is currently in Phase 2 clinical testing for mild-to-moderate Alzheimer’s disease and has been granted Fast Track designation by the U.S. FDA.
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, Elayta, is a proprietary first-in-class, orally available small molecule in development for the treatment of mild-to-moderate Alzheimer’s disease. 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.