– 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
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, any expected or implied benefits or results, including that initial preclinical and clinical results observed with respect to CT1812 will be replicated in later trials and our clinical development plans, including statements regarding our Phase 2 SHINE and Phase 1b SNAP studies of CT1812 and any analysis of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials, involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition, our ability to secure new (and retain existing) grant funding, our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data and pre-clinical studies being predictive of the results of clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impact of the COVID-19 pandemic on our business, supply chain and labor force; and the risks and uncertainties described in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
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
