Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB)

Rhea-AI Summary

Cognition Therapeutics (NASDAQ: CGTX) announced key regulatory developments for its drug zervimesine (CT1812). The company has scheduled an end-of-Phase 2 meeting with the FDA on July 9, 2025, to discuss results from the SHINE study in mild-to-moderate Alzheimer's disease and plans for Phase 3 trials.

Additionally, following positive Phase 2 SHIMMER study results, CGTX has submitted applications for both breakthrough therapy designation and IND approval for Dementia with Lewy Bodies (DLB). The company is also progressing with an expanded access program (EAP) for DLB patients, with high interest among former SHIMMER study participants.

Positive

• Scheduled FDA end-of-Phase 2 meeting indicates progression toward Phase 3 trials for Alzheimer's disease
• Submitted applications for breakthrough therapy designation and IND for DLB treatment
• High interest in expanded access program (EAP) from former SHIMMER study participants
• Positive Phase 2 SHIMMER study results in DLB patients

Negative

• Only one site currently open for the expanded access program
• Breakthrough therapy designation and IND approval still pending FDA review

Insights

Neuroscience and Drug Development Expert

Positive regulatory progress for Cognition's zervimesine in two neurological conditions shows momentum toward commercialization pathways.

Cognition Therapeutics is making significant regulatory strides with its lead candidate zervimesine (CT1812) across two major neurodegenerative conditions. The scheduled end-of-Phase 2 FDA meeting for Alzheimer's disease represents a critical milestone, as it will determine whether their Phase 2 SHINE study data is sufficient to advance into pivotal Phase 3 trials. This is a crucial inflection point that typically signals a drug's transition from mid-stage to late-stage development.

In parallel, the company has submitted both an IND application and breakthrough therapy designation request for zervimesine in Dementia with Lewy Bodies (DLB) based on positive Phase 2 SHIMMER study results. This dual-pronged regulatory approach is strategically sound, as breakthrough designation could accelerate development timelines through enhanced FDA collaboration and priority review.

The expanded access program (EAP) for DLB patients indicates two important factors: first, that early clinical results were promising enough to warrant compassionate use, and second, that the company maintains confidence in the drug's safety profile. The "high interest" among former study participants suggests positive patient experiences with the treatment.

This regulatory momentum positions Cognition to potentially advance two programs toward commercialization, addressing significant unmet needs in neurodegeneration. However, investors should note that while promising, these are still regulatory stepping stones rather than approval decisions, with Phase 3 trials (particularly in Alzheimer's) historically representing significant hurdles with high failure rates.

- End-of-Phase 2 Meeting with FDA for Mild-to-Moderate Alzheimer’s Disease Scheduled -

- Applications for IND and Breakthrough Status Filed for Dementia with Lewy Bodies -

PURCHASE, N.Y., June 25, 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 company will conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. During the meeting, the Cognition team will review results of the Phase 2 'SHINE’ study (NCT03507790) of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease. In addition, proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population will be discussed with the FDA.

“We believe we have a compelling proposal to advance zervimesine into a Phase 3 registrational program for mild-to-moderate Alzheimer’s disease,” stated Lisa Ricciardi, Cognition’s president and CEO. “In parallel we are moving ahead with DLB and formulating plans to conduct a registrational program. Based on the positive Phase 2 ‘SHIMMER’ study (NCT05225415) results in DLB, we submitted an application to be considered for breakthrough therapy designation along with the investigational new drug (IND) application.”

Breakthrough therapy designation is designed by the FDA to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions where preliminary clinical evidence suggests substantial improvement over existing treatments. The designation facilitates more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for rolling submission and priority review. The FDA typically reviews applications for breakthrough designation within 60 days.

The expanded access program (EAP) for zervimesine in DLB is progressing with high interest among former SHIMMER participants. The EAP is enrolling adults with DLB who participated in the SHIMMER study, as well as others who meet the program’s eligibility criteria. While one site is currently open, the Cognition team is working closely with other sites to complete onboarding so that they may be open to patients soon.

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 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 the enrollment of patients in the EAP for DLB, as well as statements regarding our regulatory plans, including our end-of-Phase 2 meeting, our plans for a Phase 3 program, and our expectations regarding the IND and breakthrough designation status for zervimesine for the treatment of DLB, 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

Casey McDonald (media)   Tiberend Strategic Advisors, Inc.      cmcdonald@tiberend.com

Mike Moyer (investors)  LifeSci Advisors  mmoyer@lifesciadvisors.com

This press release was published by a CLEAR® Verified individual.

FAQ

When is Cognition Therapeutics (CGTX) meeting with the FDA for their Alzheimer's drug zervimesine?

Cognition Therapeutics will conduct an end-of-Phase 2 meeting with the FDA on July 9, 2025 to discuss their SHINE study results and Phase 3 plans for zervimesine in mild-to-moderate Alzheimer's disease.

What regulatory applications has CGTX submitted for zervimesine in Dementia with Lewy Bodies?

CGTX has submitted applications for breakthrough therapy designation and an investigational new drug (IND) application for zervimesine in Dementia with Lewy Bodies treatment.

What is the status of CGTX's expanded access program for zervimesine in DLB?

The expanded access program is currently active with one site open and experiencing high interest from former SHIMMER study participants. Additional sites are in the process of being onboarded.

What clinical studies has CGTX completed for zervimesine?

CGTX has completed the Phase 2 SHINE study for mild-to-moderate Alzheimer's disease and the Phase 2 SHIMMER study for Dementia with Lewy Bodies, with positive results reported for the latter.