PITTSBURGH, Nov. 4, 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, announced today the presentation of the results of a randomized, multi-dose, placebo-controlled Phase 1b/2a clinical study (COG0102) of CT1812 as a Late-Breaking Oral Communication and a Late-Breaking Poster at the 10th Clinical Trials on Alzheimer’s Disease (CTAD) meeting held in Boston, MA on November 2-4, 2017.
CT1812, Cognition’s lead candidate for mild-to-moderate Alzheimer’s disease, is a highly brain penetrant small molecule that displaces amyloid beta (Aβ) oligomers from neuronal receptors, potentially allowing synapses to regenerate and cognitive performance to improve. Study COG0102 enrolled 19 individuals with mild-to-moderate Alzheimer’s disease who were randomized to receive placebo or one of three doses of CT1812 (90mg, 280mg and 560mg) for 28 days. Safety and pharmacokinetics were the primary objectives of the study, with changes in protein biomarkers and cognitive outcomes as exploratory objectives.
In Study COG0102, all three CT1812 doses were well tolerated; all adverse events were mild or moderate. There were no serious adverse events. Pharmacokinetics were consistent with previous clinical study results and CT1812 achieved cerebrospinal fluid (CSF) concentrations greater than 80 percent estimated brain receptor occupancy at all doses, a level previously demonstrated in preclinical studies to be the minimum efficacious dose. Cognitive outcomes were similar across treatment and placebo groups at the end of 28 days of dosing. This Late-Breaking Oral Communication, presented by Lon Schneider, M.D., professor of psychiatry, neurology, and gerontology at the USC Keck School of Medicine, was entitled “The Anti-Aβ Oligomer Drug CT1812 for Alzheimer’s: Phase 1b/2a Safety Trial Outcomes.”
Treatment with CT1812 resulted in changes in CSF levels of several key synaptic proteins that are dysregulated in Alzheimer’s disease, including neurogranin and synaptotagmin-1. Quantification of CSF protein levels via ELISA revealed that neurogranin, a marker of synaptic damage that is elevated in Alzheimer’s patient CSF, was significantly reduced in CT1812-treated patients. Unbiased measurement of CSF proteins via LC/MSMS* indicated that dozens of proteins changed differentially in CT1812-treated vs. placebo patients, including a marked reduction in synaptotagmin-1, another marker of synaptic damage. Data on these protein changes were presented by Susan Catalano, Ph.D., Cognition Therapeutics’ Chief Scientific Officer and founder, in a Late-Breaking Poster entitled “Biomarker Outcomes from the Phase 1b/2a Safety Trial of the Anti-Aβ Oligomer Drug CT1812 in Alzheimer’s Patients.”
Abstracts for Cognition’s presentation and poster may be found on the CTAD website following the conclusion of the meeting.
“The pharmacokinetic and proteomic findings from this study underscore the role of Aβ oligomers in Alzheimer’s disease. These data and prior safety studies are encouraging, and open the door to longer clinical trials of CT1812 with the aim of identifying cognitive benefit,” commented Dr. Schneider.
“The changes observed in protein biomarker levels after treatment with CT1812 were consistent with a positive effect on synapses as well as CT1812’s mechanism of action,” explained Dr. Catalano. “Combined with the pharmacokinetic and safety data, these encouraging findings form the foundation for further study of CT1812 in Alzheimer’s patients. We will shortly initiate clinical studies using cutting-edge imaging and protein detection technologies to confirm this positive effect on synapses, and correlate this with cognitive improvement.”
“The results of COG0102 provide important insights into the proposed mechanism of action of CT1812,” added Kenneth I. Moch, Cognition’s President and CEO. “We anticipate that the results of the next studies will help us refine our clinical development plan, paving the way for an extensive Phase 2 clinical program for CT1812.”
Cognition’s lead product candidate, CT1812, has completed a Phase 1b/2a clinical study (COG0102) in patients with mild-to-moderate Alzheimer’s disease and has been granted Fast Track designation by the US FDA. This highly brain penetrant compound targets the sigma-2 receptor complex on neuronal synapses, displacing toxic beta amyloid (Aβ) 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. Study COG0102 was support in part under Award Number RF1AG054176 from The National Institute on Aging of the National Institutes of Health.
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 http://www.cogrx.com.
* EDITOR’S NOTE: LC/MSMS, or liquid chromatography tandem mass spectrometry, is an analytical chemistry technique that combines the physical separation capabilities of liquid chromatography with the highly sensitive analysis capabilities of mass spectrometry
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.