Cognition Therapeutics’ VP of Research Co-hosting Precision Medicine Workshop at the Neuroimmunology Drug Development Summit

Rhea-AI Summary

Cognition Therapeutics (NASDAQ: CGTX) announced that Mary Hamby, PhD will co-host a precision medicine workshop at the Hanson Wade Neuroimmunology Drug Development Summit on February 25-27, 2025 in Boston.

Dr. Hamby will present findings from Cognition's Phase 2 'SHINE' study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer's disease. The study revealed that participants with lower levels of p-tau217 protein showed significant response to zervimesine treatment, scoring 95% better on the ADAS-Cog 11 scale and 108% better on the MMSE scale compared to placebo.

The workshop, titled "Patient Stratification for Precision Medicine in Neuroscience," will explore how plasma p-tau217 assays could identify Alzheimer's patients most likely to benefit from therapies addressing beta amyloid, including Cognition's oligomer antagonist zervimesine.

Positive

• Phase 2 SHINE study showed patients with lower p-tau217 levels responded 95% better on ADAS-Cog 11 scale to zervimesine
• Patients with lower p-tau217 levels scored 108% better on MMSE scale than placebo group
• Plasma p-tau217 can be measured with a simple blood test for personalized treatment

Negative

• None.

Insights

Biotech Analyst

Cognition Therapeutics' announcement about their VP of Research co-hosting a precision medicine workshop contains significant clinical data that could substantially impact the company's development strategy and market position in the Alzheimer's disease space.

The key revelation is the identification of a potential predictive biomarker (p-tau217) that could transform their clinical development approach. Patients with lower p-tau217 levels showed remarkable improvements with zervimesine treatment: 95% better scores on the ADAS-Cog 11 scale and 108% better on the MMSE scale compared to placebo. These are substantial efficacy signals in Alzheimer's trials, where even modest cognitive improvements can be clinically meaningful.

For context, the ADAS-Cog and MMSE are gold-standard cognitive assessment tools in Alzheimer's research. Improvements of this magnitude in a subpopulation suggest that Cognition may have identified a way to significantly enhance treatment efficacy through patient selection - a critical advantage in a therapeutic area plagued by high failure rates.

The biomarker strategy offers multiple strategic benefits for this $24M micro-cap company:

• Potentially streamlined clinical trials with higher success probability by focusing on responsive patients
• Reduced development costs and timelines - critical for a company with resources
• Differentiation in the competitive Alzheimer's market where antibody therapies from larger players have shown modest benefits with significant side effects
• Possible companion diagnostic opportunity through the p-tau217 blood test, creating additional intellectual property and revenue potential

Zervimesine's mechanism as an oligomer antagonist offers a different approach from antibody therapies like Leqembi and Aduhelm. This mechanistic differentiation, combined with the precision medicine strategy, could carve out a significant market position despite competition from pharmaceutical giants.

While this Phase 2 data requires confirmation in larger trials, the precision medicine approach may significantly de-risk their development pathway. For investors in this micro-cap biotech, this biomarker strategy substantially improves the risk-reward profile by potentially increasing the probability of clinical and regulatory success in one of medicine's most challenging therapeutic areas.

PITTSBURGH, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today announced that Mary Hamby, PhD will be co-hosting a precision medicine workshop at the Hanson Wade Neuroimmunology Drug Development Summit. The workshop will review methods of screening participants for clinical trials to ensure that the patients selected are most likely to benefit from treatment.

Dr. Hamby will present an overview of the findings from Cognition’s Phase 2 ‘SHINE’ study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer’s disease. Participants with lower levels of a protein called p-tau217 at the beginning of the SHINE study experienced a robust response to zervimesine treatment. Specifically, these individuals with lower p-tau217 levels scored 95% better on the ADAS-Cog 11 scale and 108% better on the MMSE scale than did their counterparts on placebo.

“In addition to its value as a diagnostic test, based on the results from our Phase 2 SHINE study, we believe plasma p-tau217 assays have the potential to identify Alzheimer’s patients most likely to benefit from therapies that address beta amyloid (Aβ), either directly with immunotherapies or indirectly with an oligomer antagonist like zervimesine,” stated Dr. Hamby. “Plasma p-tau217 can be measured using a simple blood test, providing patients and their physicians with an important tool they can use to tailor their personalized treatment regimens.”

The Hanson Wade Neuroimmunology Drug Development Summit is taking place February 25-27, 2025 in Boston, MA. The workshop, titled “Patient Stratification for Precision Medicine in Neuroscience: How Can We Ensure the Right Patients are Enrolled on the Right Drugs to Treat Their Specific Disease Pathology?” will be hosted by Dr. Hamby and Jiri Aubrecht, VP and head of clinical biomarkers at Prothena. More information may be found at https://neuroimmunology-drugdevelopment.com/.

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 are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer’s disease, including the ongoing START study (NCT05531656) in early Alzheimer’s disease. 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 and any analyses 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, 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 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 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 Global 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

What were the key findings from CGTX's Phase 2 SHINE study of zervimesine?

Patients with lower p-tau217 levels showed robust response to zervimesine, scoring 95% better on ADAS-Cog 11 scale and 108% better on MMSE scale compared to placebo.

How does Cognition Therapeutics (CGTX) plan to use p-tau217 in Alzheimer's treatment?

CGTX believes plasma p-tau217 assays can identify Alzheimer's patients most likely to benefit from beta amyloid-targeting therapies, including their oligomer antagonist zervimesine.

What is the significance of p-tau217 for CGTX's Alzheimer's drug development?

P-tau217 serves as both a diagnostic marker and a potential predictor of treatment response to zervimesine, allowing for more targeted patient selection in clinical trials.

When and where is Cognition Therapeutics presenting their SHINE study results?

CGTX's VP of Research will present at the Hanson Wade Neuroimmunology Drug Development Summit taking place February 25-27, 2025 in Boston, MA.

What advantage does CGTX's approach offer for Alzheimer's patient screening?

CGTX's approach uses a simple blood test measuring plasma p-tau217, providing an accessible tool for physicians to tailor personalized treatment regimens for Alzheimer's patients.