Cognition Therapeutics Publishes Clinical Evidence that CT1812 Displaces Aβ Oligomers from Binding to Neuronal Synapses in Alzheimer’s Disease

- First Human Evidence that CT1812 Selectively Engages Aβ Oligomers

PURCHASE, N.Y., May 18, 2023 (GLOBE NEWSWIRE) --  Cognition Therapeutics, Inc. (NASDAQ: CGTX), today announced that a manuscript entitled, “A Phase 1b Randomized Clinical Trial of CT1812 to Measure Aβ Oligomer Displacement in Alzheimer’s Disease Using an Indwelling CSF Catheter” (doi: 10.1186/s40035-023-00358-w) has been published in the journal, Translational Neurodegeneration.

“By evaluating hourly changes in beta amyloid (Aβ) oligomer concentrations in the cerebrospinal fluid (CSF) of individuals with mild-to-moderate Alzheimer’s disease, we were able to observe the impact of CT1812 target engagement,” stated Mary Hamby, PhD, VP of research. “Data from the Phase 1b SNAP study (COG0104, NCT03522129) mirror findings from our preclinical studies showing Aβ oligomer displacement from neurons in culture and into the CSF in transgenic mice. We believe these findings provide confirmatory evidence that CT1812 engages its target, the sigma-2 (σ-2) receptor, and through this interaction causes rapid displacement of Aβ oligomers from their binding sites on synapses into the CSF.”

“SNAP and our other initial clinical studies, including SPARC and SEQUEL, the latter of which recently concluded enrollment, have focused on assessing fluid, physiological and imaging biomarkers, and have provided important insights into the impact CT1812 may have on the binding of oligomeric Aβ to synapses, as well as its impact on brain volume and brain circuitry,” explained Anthony O. Caggiano, MD, PhD,” Cognition’s CMO and head of R&D. “Looking ahead, these findings give us confidence in our ongoing Phase 2 SHINE study, which will evaluate the safety and tolerability of CT1812 and further investigate how its engagement of the σ-2 receptor translates into clinical benefit.”

Findings from the SNAP study demonstrate that a single oral dose of CT1812 rapidly displaces Aβ oligomers from synapses. This was shown by a marked temporal increase in CSF Aβ oligomer levels after a single dose of CT1812. In comparison, no change was observed in Aβ oligomers levels following administration of placebo. In this study of three individuals with Alzheimer’s disease, CT1812 was well-tolerated, and no serious adverse events were related to study medication, but instead were due to the lumbar puncture procedure for the indwelling catheter used for CSF sampling.

Clinical results from the SNAP study mirror preclinical findings that showed that Aβ oligomer levels in the CSF of transgenic mice could be increased after a single dose of CT1812 (Izzo et al., Alzheimer's Dement, 2021). In in vitro studies, the displacement of oligomers by CT1812 resulted in the restoration of synapses, which in a preclinical Alzheimer's model was associated with an improvement in cognitive function.

Publication Citation:
LaBarbera, K.M., Sheline, Y.I., Izzo, N.J. et al. A Phase 1b Randomized Clinical Trial of CT1812 to Measure Aβ Oligomer Displacement in Alzheimer’s Disease Using an Indwelling CSF Catheter. Transl Neurodegener 12, 24 (2023). https://doi.org/10.1186/s40035-023-00358-w

About the SNAP Study
The SNAP study was a randomized, double-blind, placebo-controlled trial of CT1812 in three adults with mild-to-moderate Alzheimer’s disease. Enrolled patients had an indwelling catheter placed in the lumbar CSF space, from which CSF samples were collected hourly for 28 hours. Five samples were collected prior to administration of a single 560 mg oral dose of CT1812, or placebo and 24 samples were collected following administration. Aβ oligomer levels were measured via microimmunoelectrode and native Western Blots assays.

About Cognition Therapeutics, Inc.
Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We are currently investigating our lead candidate CT1812 in clinical programs in Alzheimer’s disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration (dry AMD). We believe CT1812 and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the σ-2 receptor with CT1812 represents a mechanism functionally distinct from other current approaches in clinical development for the treatment of degenerative diseases. More about Cognition Therapeutics and its pipeline can be found at https://cogrx.com.

Forward Looking Statements
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Contact Information:
Cognition Therapeutics, Inc. 
info@cogrx.com  

Bill Borden (media) 
Tiberend Strategic Advisors, Inc.  
bborden@tiberend.com   

Daniel Kontoh-Boateng (investors) 
Tiberend Strategic Advisors, Inc. 
dboateng@tiberend.com