- Cognition and FDA align on enriched population, study design, and endpoints -
PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of-Phase 2 meeting that was conducted on July 9, 2025. FDA confirmed the proposed design of the Phase 3 program may support a New Drug Application (NDA) filing for zervimesine (CT1812) as a treatment for Alzheimer’s disease.
Based on the FDA’s feedback, the Phase 3 program is expected to enroll adults with a diagnosis of mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening. Previous clinical experience* has shown that zervimesine can arrest cognitive deterioration in this population by 95% compared to placebo. This degree of cognitive preservation in zervimesine-treated patients supports plasma p-tau217 as a predictive biomarker of robust treatment effect. Screening for p-tau217 levels in Phase 3 will therefore enrich the study population with patients most likely to benefit from zervimesine treatment.
“In the meeting minutes, FDA concurred with our plan to enrich the Phase 3 study population with Alzheimer’s patients who have lower p-tau217,” stated Anthony Caggiano, MD, PhD, Cognition’s CMO and head of R&D. “Because p-tau217 can be measured by a simple blood test, we expect this strategy will ease the burden on patients. This enrichment strategy may increase the power of the study and reduce trial costs.”
Participants will be randomized to either 100mg of oral zervimesine or placebo daily for six months. Efficacy and safety will be assessed, with endpoints affirmed by the FDA in the meeting minutes. Cognition also plans to include biomarker and imaging assessments in the Phase 3 program to support the clinical outcomes. Participants who complete either study will be eligible to enroll in an open-label extension study.
“Based on the end-of-Phase 2 meeting minutes, we are aligned with the FDA on a registrational plan for zervimesine that includes details of study enrichment, treatment duration, endpoints, and availability of an open-label extension,” stated Lisa Ricciardi, president and CEO of Cognition. “One of the most important outcomes from the meeting was the FDA’s view that two six-month Phase 3 studies could support a new drug application for zervimesine. This plan allows us to enroll faster, more cost-effective studies, and brings us to a regulatory filing sooner. We look forward to continuing our dialogue with the FDA as we propel zervimesine forward.”
* Results from the Phase 2 “SHINE” study in mild-to-moderate Alzheimer’s disease showed that participants treated with zervimesine who had lower plasma p-tau217 levels experienced a 95% slowing of cognitive decline as measured by ADAS-Cog11 when compared with placebo.
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 receptors on the surface of 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. Zervimesine has been shown to interrupt the toxic effects of Aβ and ɑ-synuclein, which may 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 SHINE Study
The COG0201 ‘SHINE’ Study was a double-blind, placebo-controlled Phase 2 study that enrolled 153 adults with mild-to-moderate Alzheimer’s disease. The study met its primary endpoints of safety and tolerability. Changes in cognition (ADAS-Cog 11, cognitive composite and MMSE) and function (ADCS-ADL and ADCS-CGIC) were also measured. Participants were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months.
The SHINE Study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. More information may be found at clinicaltrials.gov under trial ID NCT03507790.
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 with $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health. 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, as well as statements regarding our regulatory plans, including our end-of-Phase 2 meeting, and our designs and plans for our Phase 3 program, 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.
| Contact Information: Cognition Therapeutics, Inc. info@cogrx.com | Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com |
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