Pittsburgh, July 23, 2018 — Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on synaptic health and restoration in neurodegenerative disorders, today announced that co-founder and Chief Science Officer Susan Catalano, Ph.D. presented additional findings supporting the unique synaptorestorative mechanism of action of Elayta™ (CT1812), Cognition’s lead candidate for the treatment of mild-to-moderate Alzheimer’s disease, at the Alzheimer’s Association International Conference (AAIC) in Chicago. Dr. Catalano was invited by the Association to present these results as part of the July 23rd Symposium Session: Translational Research In Reality – What Are The Criteria From Concept To Clinic?
As part of her presentation, Dr. Catalano’s discussed ongoing and future clinical plans for Elayta including the recently initiated SNAP and SPARC studies, both of which employ unique measurement techniques that may prove to be critical tools in the diagnosis of Alzheimer’s disease and the measurement of treatment effects.
SNAP is the first study to employ highly sensitive methods of measuring Aꞵ oligomers in the cerebrospinal fluid (CSF) pioneered by John Cirrito, Ph.D. at the Hope Center for Neurological Disorders at Washington University in St. Louis. Medical literature suggests that clearing toxic oligomers out of the brain may therapeutically benefit patients with Alzheimer’s disease. Dr. Cirrito and colleagues developed new methods of oligomer detection that are being used for the first time in the SNAP study. These measurement techniques have the potential to measure the displacement of Aβ oligomers from their binding sites on synapses and the subsequent clearance into the CSF, key features of Elayta’s mechanism of action.
SPARC is the first longitudinal study to image synaptic density in patients with Alzheimer’s disease utilizing a pioneering methodology developed by Christopher van Dyck, M.D. at the Yale Alzheimer’s Disease Research Unit and Richard E. Carson, Ph.D. at the Yale PET Imaging Center. This methodology employs positron emission tomography (PET) imaging with a carbon-11-labeled radioligand tracer, UCB-J, that is selective for synaptic vesicle glycoprotein 2A (SV2A), a membrane protein expressed in the majority of synapses. Historically, synapse density was only able to be quantified postmortem; the results to date from Drs. van Dyck’s and Carson’s studies represent the first time synapse density has been measured in living people. Furthermore, the study confirmed a reduction in synapse density in patients with Alzheimer’s disease compared to cognitively normal individuals. The results of Drs. Van Dyck and Carson’s work were recently published in JAMA Neurology in an article titled Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging.
“This approach may provide a direct measure of synaptic density, and it therefore holds promise as an in vivo biomarker for AD and as an outcome measure for trials of disease-modifying therapies, particularly those targeted at the preservation and restoration of synapses,” the authors stated in the article.
About Elayta (CT1812)
Cognition’s lead product candidate, Elayta (CT1812), a highly brain penetrant small molecule with a unique disease-modifying synaptorestorative mechanism of action, is currently in Phase 2 clinical testing for mild-to-moderate Alzheimer’s disease. This orally dosed drug candidate, which was discovered by Cognition’s scientific team led by Susan Catalano, Ph.D., facilitates the restoration and protection of synaptic function by selectively displacing toxic beta amyloid oligomers (AβOs) from their synaptic receptors, thus stopping downstream damage and improving memory function. Consistent with these findings, Cognition’s Phase 1b/2a clinical trial (COG0102) demonstrated that Elayta significantly reduces concentrations of synapse damage proteins in the cerebrospinal fluid of Alzheimer’s patients. Elayta has been granted Fast Track designation by the U.S. FDA.
Patient dosing recently commenced in two clinical studies of Elayta: SPARC (Synaptic Protection for Alzheimer’s Restoration of Cognition) and SNAP (AβO Displacement from Synapses on Neurons in Alzheimer’s Patients). SNAP and SPARC are funded by grants from the National Institute on Aging of the National Institute of Health (award numbers RF1AG057780 and RF1AG057553.)
About the SNAP and SPARC Studies of Elayta
SNAP, which is being conducted at the University of Pennsylvania, will randomized up to 18 mild-to-moderate AD patients who are positive for beta amyloid (Aβ) to receive a single dose of either Elayta or placebo. Cerebrospinal fluid (CSF) of study participants will be sampled at baseline and hourly for 24 hours and the concentration of Aβ oligomers (AβOs) in the CSF will be measured using novel highly sensitive methods of AβO measurement. Evidence of an increase in the clearance of Aβ oligomers into the CSF would be a meaningful finding given that many consider Alzheimer’s disease to be triggered by the declining clearance of beta amyloid that occurs with age.
SPARC, which is being conducted at the Yale Alzheimer’s Disease Research Unit, is a randomized, double-blind, placebo-controlled study designed to compare changes in synaptic density in 21 Alzheimer’s disease patients who will receive treatment with Elayta or placebo once daily for 24 weeks. Synaptic density will be determined at baseline and after 12 and 24 weeks of dosing using positron emission tomography (PET) imaging with a carbon-11-labeled radioligand tracer, UCB-J, that is selective for synaptic vesicle glycoprotein 2A (SV2A), a membrane protein expressed in the majority of synapses. The outcome of this first-of-its-kind study is anticipated to add to the body of evidence that Elayta not only protects synapses but enables a reversal of synaptic damage and loss – “synaptic restoration.”
About Cognition Therapeutics, Inc.
Cognition Therapeutics is a privately held biopharmaceutical company focused on synaptic health and restoration in neurocognitive disorders through a pipeline of disease modifying small molecule drug candidates. Cognition’s lead candidate, Elayta, is a proprietary first-in-class, orally available small molecule that has shown synaptorestorative potential and is 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.