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Cognition Therapeutics Highlights Phase 2 SHIMMER Study of CT1812 in Dementia with Lewy Bodies in Presentation at CTAD

CGTX

Innovative trial addresses second most common dementia after Alzheimer’s disease, now enrolling patients at up to 30 activated sites across the USA

PURCHASE, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (Nasdaq: CGTX), (the “Company” or “Cognition”), today announced that the rationale and design of the Company’s ongoing SHIMMER clinical trial of CT1812 will be presented at the 2022 Clinical Trials in Alzheimer’s Disease (CTAD) conference. The Phase 2 SHIMMER (COG1201) study is intended to assess the safety, tolerability, and efficacy of CT1812 in individuals with dementia with Lewy bodies (DLB). CT1812 is a novel oral, once-daily small-molecule therapeutic designed to protect neurons from pathogenic forms of proteins such as a-synuclein and beta amyloid (Aß) by preventing oligomers from binding to synapses.

There are currently no approved treatments for DLB, which impacts an estimated 1.4 million people in the United States, making it the second most common form of dementia. Patients may present with symptoms including cognitive or motor deficits, or changes in behavior (sleep disorders, hallucinations, anxiety), which can masquerade as other conditions, making it challenging to correctly diagnose DLB. It is believed that aggregated forms of a-synuclein and Aß bind to neurons, triggering failures in protein trafficking and other key cellular functions. Such a catastrophic failure in cellular function eventually leads to the loss of neurons, driving disease pathology and giving rise to the constellation of symptoms associated with DLB.

“We have published research1 demonstrating that s-2 receptor modulators such as CT1812 can be effective in reversing the trafficking deficits caused by a-synuclein oligomers in in vitro models,” stated Anthony Caggiano, M.D., Ph.D., chief medical officer and head of R&D at Cognition. “This proof-of-principle data, combined with the encouraging safety signals in our Alzheimer's disease program, gave us the confidence to move forward into our Phase 2 SHIMMER trial of CT1812 in DLB.”

The Company is conducting the study in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA) with non-dilutive grant funding of approximately $30 million from the National Institute on Aging (NIA). The SHIMMER study is being conducted at over 30 sites in the United States, many of which are LBDA centers of excellence.

The Phase 2 SHIMMER trial will enroll approximately 120 adults with mild-to-moderate DLB, who will be randomized to receive placebo or once-daily oral doses of CT1812 for six months. In addition to safety, this study will compare changes in cognitive performance and physical activity using an innovative Clinical Global Impression of Change tool that has been modified to provide DLB-specific prompts on cognition, motor, behavioral, sleep and autonomic features. More details on the study and its inclusion and exclusion criteria may be found on www.clinicatrials.gov.

Poster details

Date/Time: 4:00pm PT on November 29th through 6:00pm PT on November 30th
Title: A Phase 2 Study of the Sigma-2 Ligand CT1812 in Participants with Dementia with Lewy Bodies (P027)
Authors: James Galvin, Magdalena Tolea, Michael Grundman, Mary Hamby, Anthony Caggiano

About Dementia with Lewy Bodies
An estimated 1.4 million Americans are living with DLB, a progressive disease that accounts for approximately 5-10% of all dementia cases. DLB has overlapping pathology and symptomology of Parkinson’s and Alzheimer’s diseases, making it challenging to diagnose. DLB is caused by a build-up of a protein, a-synuclein, which forms deposits, called Lewy bodies, in the brain. Oligomers of a-synuclein are highly toxic and bind to neurons where they impair critical cellular processes, causing synaptic dysfunction and loss. Patients with DLB often experience cognitive, physical, sleep and behavioral symptoms, including hallucinations, delusions and mood changes. There are currently no disease-modifying treatments approved for DLB patients.

About Cognition Therapeutics
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 s-2 receptor modulators can regulate pathways that are impaired in these diseases. We believe that targeting the s-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/

1 Limegrover CS et al. Sigma‐2 receptor antagonists rescue neuronal dysfunction induced by Parkinson’s patient brain‐derived a‐synuclein. J Neurosci Res. 2021; 00: 1– 16.

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 cash and financial resources and our clinical development plans, are forward-looking statements. These statements 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) non-dilutive 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; 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 we may be adversely affected by other economic, business or competitive factors; 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” sections of our filings with the Securities Exchange Commission. 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

Aline Sherwood (media)
Scienta Communications
asherwood@scientapr.com

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


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