Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer's Disease Surpasses 50% Enrollment Target

PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ:CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START' Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer's Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health.

Christopher van Dyck, MD, stated, "This is an important milestone for the study and is a testament to the commitment of the investigators and site teams and a high level of interest from participants in an oral treatment with a novel approach to addressing amyloid in early Alzheimer's disease." Dr. Van Dyck is the director of the Yale Alzheimer's Disease Research Unit and the Yale Alzheimer's Disease Research Center. He also serves as a member of the ACTC executive committee and is the project director of the START Study.

The START Study (NCT05531656) is designed to enroll up to 540 individuals with mild Alzheimer's disease who will be treated with zervimesine (CT1812) or placebo for 18 months. Participants are being enrolled at approximately 50 sites in the United States, including premier institutions in the ACTC network. More information about this study may found at https://start-study.org.

"Participants in the START Study are just beginning to show signs of cognitive loss," stated Anthony O. Caggiano, MD, PhD, Cognition's CMO and head of R&D. "Based on our experience from the Phase 2 ‘SHINE' Study in mild-to-moderate Alzheimer's disease, we expect that patients with less disease pathology may experience the most benefit from zervimesine treatment. We look forward to working with our colleagues at ACTC to understand more about zervimesine's potential in patients across the spectrum of Alzheimer's disease."

In the Phase 2 SHINE Study (NCT03507790), once-daily oral zervimesine treatment slowed cognitive decline by 38% compared to placebo. Participants with lower levels of the protein, p-tau217 in their blood plasma had a more robust treatment response, experienced a 95% slowing of their cognitive decline. Lower levels of p-tau217 may identify people who have not yet sustained severe neuronal loss, offering them a greater potential for treatment response.

About Zervimesine (CT1812)

Zervimesine (CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer's disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain – Aβ and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person's ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer's and DLB. Zervimesine has been generally well tolerated in clinical studies to date.

The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.

About the START Study

The START study will measure the efficacy and tolerability of once-daily oral CT1812 in individuals with mild cognitive impairment or early Alzheimer's disease (MMSE 20-30) who have elevated Aβ (as measured by PET or CSF). Participants will be randomized to receive CT1812 or placebo for 18 months. The study will assess cognition and executive function using validated tools including the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales, as well as biomarker and safety findings.

The START study is supported by a grant from the National Institute of Aging (NIA) at the National Institutes of Health (R01AG065248). The study is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC), an NIA-funded (grant number U24AG057437) clinical trial network of 35 leading academic sites with expertise in clinical trials in Alzheimer's disease.

About Cognition Therapeutics, Inc.

Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We recently completed Phase 2 studies of our lead candidate, zervimesine (CT1812) in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer's disease and geographic atrophy secondary to dry AMD. The Phase 2 START study (NCT05531656) in early Alzheimer's disease is ongoing. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our 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 or made during the conference, 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, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom and our expectations regarding the enrollment of patients in in our START study, 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, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage 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 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 impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the "Risk Factors" section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. 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.

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