Cognition Therapeutics to Report Biomarker Results from Phase 2 SHINE Study in Mild-to-Moderate Alzheimer’s Disease in Podium Presentation at AD/PD 2025
Cognition Therapeutics (NASDAQ: CGTX) will present biomarker results from their Phase 2 SHINE study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Conference in Vienna. The presentation, scheduled for April 1-5, 2025, will focus on analyzing key blood sample biomarkers including neurofilament light chain, glial fibrillary acidic protein, amyloid beta, and tau species.
Dr. Mary Hamby, VP of research, will deliver a podium presentation examining the drug's impact on disease biology by comparing biomarker changes between zervimesine and placebo groups. The presentation will complement previously reported positive cognitive and functional findings to provide a comprehensive understanding of the drug's effectiveness.
Additional poster presentations will cover CSF proteomic biomarker analysis, correlation of CSF proteins with cognitive outcomes, and molecular correlates with CT1812 treatment-related changes in NfL CSF levels.
Cognition Therapeutics (NASDAQ: CGTX) presenterà i risultati dei biomarcatori del loro studio di Fase 2 SHINE su zervimesine (CT1812) nella malattia di Alzheimer da lieve a moderata durante la Conferenza AD/PD™ 2025 a Vienna. La presentazione, prevista per il 1-5 aprile 2025, si concentrerà sull'analisi dei principali biomarcatori nei campioni di sangue, inclusi la catena leggera della neurofilamento, la proteina acida fibrillare gliale, l'amiloide beta e le specie di tau.
La Dr.ssa Mary Hamby, VP della ricerca, terrà una presentazione al podio esaminando l'impatto del farmaco sulla biologia della malattia confrontando le modifiche ai biomarcatori tra i gruppi di zervimesine e placebo. La presentazione completerà i risultati cognitivi e funzionali positivi precedentemente riportati per fornire una comprensione completa dell'efficacia del farmaco.
Ulteriori presentazioni poster tratteranno l'analisi dei biomarcatori proteomici nel liquido cerebrospinale, la correlazione delle proteine del liquido cerebrospinale con i risultati cognitivi e i correlati molecolari con le modifiche nei livelli di NfL del liquido cerebrospinale correlate al trattamento con CT1812.
Cognition Therapeutics (NASDAQ: CGTX) presentará los resultados de biomarcadores de su estudio de Fase 2 SHINE sobre zervimesina (CT1812) en la enfermedad de Alzheimer leve a moderada en la Conferencia AD/PD™ 2025 en Viena. La presentación, programada para el 1-5 de abril de 2025, se centrará en el análisis de biomarcadores clave en muestras de sangre, incluidos la cadena ligera de neurofilamento, la proteína ácida fibrilar glial, el beta-amiloide y las especies de tau.
La Dra. Mary Hamby, VP de investigación, realizará una presentación en el podio examinando el impacto del fármaco en la biología de la enfermedad al comparar los cambios en biomarcadores entre los grupos de zervimesina y placebo. La presentación complementará los hallazgos cognitivos y funcionales positivos reportados anteriormente para proporcionar una comprensión integral de la efectividad del fármaco.
Presentaciones adicionales en formato póster cubrirán el análisis de biomarcadores proteómicos en el líquido cefalorraquídeo, la correlación de proteínas del líquido cefalorraquídeo con los resultados cognitivos y los correlatos moleculares de los cambios en los niveles de NfL del líquido cefalorraquídeo relacionados con el tratamiento con CT1812.
Cognition Therapeutics (NASDAQ: CGTX)는 비엔나에서 열리는 AD/PD™ 2025 컨퍼런스에서 제르비메신 (CT1812)의 경증에서 중등증 알츠하이머병에 대한 2상 SHINE 연구의 바이오마커 결과를 발표할 예정입니다. 2025년 4월 1일부터 5일까지 예정된 발표는 신경섬유 경량 사슬, 아교섬유 산성 단백질, 아밀로이드 베타 및 타우 종을 포함한 주요 혈액 샘플 바이오마커 분석에 중점을 둘 것입니다.
연구 부사장인 메리 햄비 박사는 제르비메신과 위약 그룹 간의 바이오마커 변화를 비교하여 약물이 질병 생물학에 미치는 영향을 조사하는 발표를 진행할 것입니다. 이 발표는 약물의 효과에 대한 포괄적인 이해를 제공하기 위해 이전에 보고된 긍정적인 인지 및 기능적 발견을 보완할 것입니다.
추가 포스터 발표에서는 뇌척수액 단백질체 바이오마커 분석, 뇌척수액 단백질과 인지 결과 간의 상관관계, CT1812 치료와 관련된 NfL 뇌척수액 수준 변화에 대한 분자적 상관관계를 다룰 것입니다.
Cognition Therapeutics (NASDAQ: CGTX) présentera les résultats des biomarqueurs de son étude de Phase 2 SHINE sur zervimesine (CT1812) dans la maladie d'Alzheimer légère à modérée lors de la conférence AD/PD™ 2025 à Vienne. La présentation, prévue du 1er au 5 avril 2025, se concentrera sur l'analyse des biomarqueurs clés dans les échantillons de sang, y compris la chaîne légère de neurofilament, la protéine acide fibrillaire gliale, l'amyloïde bêta et les espèces de tau.
Dr. Mary Hamby, VP de la recherche, fera une présentation au podium examinant l'impact du médicament sur la biologie de la maladie en comparant les changements de biomarqueurs entre les groupes de zervimesine et de placebo. La présentation complétera les résultats cognitifs et fonctionnels positifs précédemment rapportés pour fournir une compréhension complète de l'efficacité du médicament.
Des présentations supplémentaires sous forme de posters couvriront l'analyse des biomarqueurs protéomiques dans le liquide céphalorachidien, la corrélation des protéines du liquide céphalorachidien avec les résultats cognitifs et les corrélats moléculaires des changements des niveaux de NfL dans le liquide céphalorachidien liés au traitement par CT1812.
Cognition Therapeutics (NASDAQ: CGTX) wird die Biomarkerergebnisse ihrer Phase-2-Studie SHINE zu Zervimesin (CT1812) bei leichter bis mäßiger Alzheimer-Krankheit auf der AD/PD™ 2025-Konferenz in Wien präsentieren. Die Präsentation, die für den 1.-5. April 2025 geplant ist, wird sich auf die Analyse wichtiger Biomarker in Blutproben konzentrieren, einschließlich der leichten Neurofilamentkette, des glialen fibrillären sauren Proteins, des Amyloid-Beta und der Tau-Spezies.
Dr. Mary Hamby, VP der Forschung, wird eine Podiumspräsentation halten, die die Auswirkungen des Medikaments auf die Krankheitsbiologie untersucht, indem sie die Biomarkerveränderungen zwischen den Zervimesin- und Placebogruppen vergleicht. Die Präsentation wird die zuvor berichteten positiven kognitiven und funktionalen Ergebnisse ergänzen, um ein umfassendes Verständnis der Wirksamkeit des Medikaments zu bieten.
Zusätzliche Posterpräsentationen werden die Analyse proteomischer Biomarker im Liquor cerebrospinalis, die Korrelation von Liquorproteinen mit kognitiven Ergebnissen und molekulare Korrelate mit CT1812-bezogenen Veränderungen der NfL-Liquor-Spiegel abdecken.
- Previous cognitive and functional findings were positive
- Multiple biomarker analyses to validate drug effectiveness
- None.
Insights
Cognition Therapeutics' announcement regarding their Phase 2 SHINE study of zervimesine (CT1812) represents potentially significant progress in Alzheimer's treatment development. The planned presentation at AD/PD 2025 will focus on crucial biomarkers including neurofilament light (NfL) chain, glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and phosphorylated tau species—all established indicators of Alzheimer's pathology and progression.
What makes this announcement noteworthy is the reference to "positive cognitive and functional findings" from the study. This language suggests zervimesine demonstrated measurable clinical benefits in mild-to-moderate Alzheimer's patients, though the magnitude of these benefits remains undisclosed pending the full presentation.
The multi-faceted biomarker analysis approach is scientifically sound. By examining both plasma and CSF biomarkers alongside cognitive outcomes, Cognition is building a comprehensive dataset that could validate zervimesine's mechanism through the sigma-2 receptor pathway. The specific mention of correlations between biomarkers and cognitive improvements suggests the company has identified potential predictive markers of treatment response.
For context, successful identification of pharmacodynamic biomarkers of target engagement could significantly strengthen the development program by providing objective biological evidence of drug activity. This is particularly valuable in neurodegenerative disease trials where clinical endpoints can be variable and challenging to measure.
This announcement from Cognition Therapeutics contains several key positive signals for investors following this micro-cap company (market cap:
The planned podium presentation—rather than just a poster—at AD/PD 2025 suggests the data merits prominent showcasing within the scientific community. The presentation title explicitly states "Positive Impact" of CT1812 treatment that "Aligns with Clinical Benefits," providing further confirmation of favorable results.
Particular attention should be paid to the analysis correlating biomarkers with cognitive outcomes, as establishing such relationships could significantly de-risk future clinical development by providing surrogate endpoints and patient selection strategies. The focus on p-tau217 subgroups also indicates potential for precision medicine approaches that could enhance efficacy signals in targeted populations.
For a company of this size, positive Phase 2 data in Alzheimer's disease represents a substantial value inflection point. The Alzheimer's treatment landscape has evolved significantly in recent years with the approval of disease-modifying antibodies, creating renewed investor interest in novel mechanistic approaches like Cognition's sigma-2 receptor modulation, which differs from mainstream amyloid-targeting strategies.
Additional Analyses to be Presented at AD/PD Include Correlation of CSF Biomarkers with Cognitive Outcomes, and Pharmacodynamic Biomarkers of Target Engagement
PURCHASE, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.
Mary Hamby, Ph.D., Cognition Therapeutics’ VP of research will present findings from the SHINE study during a podium presentation at the conference. Her address will focus on the analysis of key proteins, called biomarkers, that were collected in blood samples during the study. Biomarkers of interest include neurofilament light (NfL) chain, glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and tau species (p-Tau217 and p-Tau218), all of which are associated with the progression of Alzheimer’s disease.
Dr. Hamby explained, “We can gain insight on the impact of zervimesine on disease biology by assessing changes in these biomarkers in participants receiving zervimesine compared to those receiving placebo. Taken together with the positive cognitive and functional findings, these biomarker findings give us a more complete understanding of the drug’s impact on the disease.”
More details of Dr. Hamby’s presentation as well as other supportive poster presentation are found below:
Details of Cognition’s presentation and posters at AD/PD 2025 are as follows:
I. Positive Impact of CT1812 Treatment on Plasma Biomarkers in Lower p-tau217 Subgroup Aligns with Clinical Benefits in Mild-to-Moderate AD Patients (ID 3184)
Podium presentation: 1 April 2025 at 2:45pm CET in Hall A
II. CSF Proteomic Biomarker Analysis from Phase 2 SHINE Study Identified Effects of S2R Modulator CT1812 in Alzheimer’s Disease (Poster SHIFT 02-172)
III. Identification of CSF Proteins That Correlate with Cognitive Outcomes in Participants of Phase 2 SHINE Study Evaluating Effects of CT1812 in Patients with Alzheimer's Disease (Poster SHIFT 02-277)
IV. Identification of Molecular Correlates with CT1812 Treatment-related Decrease in NfL CSF Levels Connected to Sigma-2 Receptor (Poster SHIFT 01-285)
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 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 |
FAQ
What biomarkers will be analyzed in CGTX's Phase 2 SHINE study presentation?
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