Cognition Therapeutics Presents Results at AD/PD 2025 Showing Impact of Zervimesine (CT1812) on Alzheimer’s Disease Processes
Cognition Therapeutics (NASDAQ: CGTX) presented biomarker results from their Phase 2 SHINE study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Conference. The study revealed that patients treated with zervimesine for six months showed reductions in key plasma biomarkers associated with Alzheimer's disease processes compared to placebo.
Notably, a prespecified subgroup of patients with lower initial p-Tau217 levels demonstrated more pronounced reductions in important biomarkers, including:
- Significant decreases in glial fibrillary acidic protein (GFAP), linked to neuroinflammation
- Reduced levels of neurofilament light (NfL), associated with neurodegeneration
- Lower amounts of amyloid beta (Aβ) and tau species (p-Tau217)
The findings align with the cognitive benefits observed in the study population, particularly in the low-p-Tau217 subgroup, supporting zervimesine's mechanism of action in impacting disease progression.
Cognition Therapeutics (NASDAQ: CGTX) ha presentato 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. Lo studio ha rivelato che i pazienti trattati con zervimesine per sei mesi hanno mostrato riduzioni nei principali biomarcatori plasmatici associati ai processi della malattia di Alzheimer rispetto al placebo.
È importante notare che un sottogruppo predefinito di pazienti con livelli iniziali di p-Tau217 più bassi ha dimostrato riduzioni più marcate in biomarcatori significativi, tra cui:
- Riduzioni significative della proteina acida fibrillare gliale (GFAP), collegata alla neuroinfiammazione
- Livelli ridotti di neurofilamento leggero (NfL), associati alla neurodegenerazione
- Quantità inferiori di beta amiloide (Aβ) e specie tau (p-Tau217)
I risultati sono in linea con i benefici cognitivi osservati nella popolazione dello studio, in particolare nel sottogruppo a bassa p-Tau217, supportando il meccanismo d'azione di zervimesine nell'impatto sulla progressione della malattia.
Cognition Therapeutics (NASDAQ: CGTX) presentó 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. El estudio reveló que los pacientes tratados con zervimesina durante seis meses mostraron reducciones en biomarcadores plasmáticos clave asociados con los procesos de la enfermedad de Alzheimer en comparación con el placebo.
Notablemente, un subgrupo preespecificado de pacientes con niveles iniciales bajos de p-Tau217 demostró reducciones más pronunciadas en biomarcadores importantes, incluyendo:
- Disminuciones significativas en la proteína ácida fibrilar glial (GFAP), vinculada a la neuroinflamación
- Niveles reducidos de neurofilamento ligero (NfL), asociados con la neurodegeneración
- Cantidades más bajas de beta amiloide (Aβ) y especies tau (p-Tau217)
Los hallazgos se alinean con los beneficios cognitivos observados en la población del estudio, particularmente en el subgrupo de baja p-Tau217, apoyando el mecanismo de acción de zervimesina en el impacto sobre la progresión de la enfermedad.
Cognition Therapeutics (NASDAQ: CGTX)는 AD/PD™ 2025 회의에서 경증에서 중등도 알츠하이머병에 대한 zervimesine (CT1812)의 2상 SHINE 연구에서 바이오마커 결과를 발표했습니다. 이 연구는 zervimesine으로 6개월 동안 치료받은 환자들이 위약군에 비해 알츠하이머병 과정과 관련된 주요 혈장 바이오마커에서 감소를 보였음을 밝혀냈습니다.
특히, 초기 p-Tau217 수치가 낮은 사전 지정된 환자 하위 그룹은 다음과 같은 중요한 바이오마커에서 더 뚜렷한 감소를 보였습니다:
- 신경 염증과 관련된 성상세포 섬유산성 단백질(GFAP)의 유의미한 감소
- 신경퇴행과 관련된 신경필라멘트 경량(NfL) 수치의 감소
- 아밀로이드 베타(Aβ) 및 타우 종(p-Tau217)의 낮은 양
이 결과는 연구 집단에서 관찰된 인지적 이점과 일치하며, 특히 낮은 p-Tau217 하위 그룹에서 zervimesine의 작용 메커니즘이 질병 진행에 미치는 영향을 뒷받침합니다.
Cognition Therapeutics (NASDAQ: CGTX) a présenté 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. L'étude a révélé que les patients traités avec zervimesine pendant six mois ont montré des réductions de biomarqueurs plasmatiques clés associés aux processus de la maladie d'Alzheimer par rapport au placebo.
Notamment, un sous-groupe prédéfini de patients ayant des niveaux initiaux de p-Tau217 plus faibles a montré des réductions plus marquées dans des biomarqueurs importants, notamment :
- Diminutions significatives de la protéine acide fibrillaire gliale (GFAP), liée à la neuroinflammation
- Niveaux réduits de neurofilament léger (NfL), associés à la neurodégénérescence
- Quantités plus faibles de bêta-amyloïde (Aβ) et d'espèces tau (p-Tau217)
Les résultats s'alignent avec les bénéfices cognitifs observés dans la population de l'étude, en particulier dans le sous-groupe à faible p-Tau217, soutenant le mécanisme d'action de zervimesine dans l'impact sur la progression de la maladie.
Cognition Therapeutics (NASDAQ: CGTX) hat die Biomarker-Ergebnisse aus ihrer Phase-2-Studie SHINE zu Zervimesin (CT1812) bei leicht bis mäßig schwerer Alzheimer-Krankheit auf der AD/PD™ 2025-Konferenz vorgestellt. Die Studie zeigte, dass Patienten, die sechs Monate lang mit Zervimesin behandelt wurden, im Vergleich zur Placebo-Gruppe eine Reduktion wichtiger Plasma-Biomarker, die mit den Prozessen der Alzheimer-Krankheit verbunden sind, aufwiesen.
Besonders bemerkenswert ist, dass eine vordefinierte Untergruppe von Patienten mit niedrigeren anfänglichen p-Tau217-Werten ausgeprägtere Reduktionen in wichtigen Biomarkern zeigte, darunter:
- Signifikante Abnahmen des glialen fibrillären sauren Proteins (GFAP), das mit Neuroinflammation in Verbindung steht
- Reduzierte Werte von Neurofilament leicht (NfL), die mit Neurodegeneration assoziiert sind
- Niedrigere Mengen an Beta-Amyloid (Aβ) und Tau-Spezies (p-Tau217)
Die Ergebnisse stimmen mit den kognitiven Vorteilen überein, die in der Studienpopulation beobachtet wurden, insbesondere in der Untergruppe mit niedrigem p-Tau217, und unterstützen den Wirkmechanismus von Zervimesin bei der Beeinflussung des Krankheitsverlaufs.
- Significant reduction in multiple Alzheimer's disease biomarkers after zervimesine treatment
- Strong efficacy demonstrated in prespecified low-p-Tau217 patient subgroup
- Positive correlation between biomarker changes and cognitive improvements
- Multiple supporting analyses presented at major scientific conference
- Results to biomarker data without specific cognitive improvement metrics
- Treatment effects primarily demonstrated in a subgroup rather than total population
Insights
The biomarker data from Cognition's Phase 2 SHINE study represents potentially meaningful progress in their Alzheimer's disease program. The results show that zervimesine reduced several critical Alzheimer's biomarkers compared to placebo, with particularly pronounced effects in a prespecified low p-Tau217 subgroup.
Most significant is the reduction in GFAP, a key marker of neuroinflammation, along with decreased NfL (neurodegeneration marker), amyloid beta, and tau species. These biomarker reductions correlate with the cognitive benefits previously reported, creating a consistent biological rationale for zervimesine's therapeutic effect.
This pharmacodynamic evidence strengthens Cognition's hypothesis that targeting the sigma-2 receptor can modify Alzheimer's disease processes. The identification of a responsive subpopulation (patients with lower baseline p-Tau217) is particularly valuable, as it may allow for patient stratification in future trials—potentially increasing success probability while reducing required sample sizes.
For a
Presentation Shows Pronounced Reduction in Key Plasma Biomarkers Among Prespecified Study Population
PURCHASE, N.Y., April 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented 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.
In her presentation, Mary Hamby, Ph.D., VP of research at Cognition, compared changes in key proteins, called biomarkers, in the entire study population with changes observed in participants who began the study with lower levels of a protein called p-Tau217 in their blood. This protein, which can be measured with a blood test, has emerged as an indicator of Alzheimer’s disease pathology. Analysis of this low-p-Tau217 subgroup was defined in the SHINE study design in order to examine the impact of zervimesine in people with less neurodegeneration.
In the overall study population, compared to participants treated with placebo, those who received zervimesine for six months had reductions in plasma biomarkers associated with Alzheimer’s disease processes. Further analysis showed that the SHINE low-p-Tau217 subgroup experienced a pronounced reduction in these key plasma biomarkers compared to placebo.
Most notably, significant reductions were observed in the level of glial fibrillary acidic protein (GFAP), a protein associated with neuroinflammation. Neurofilament light (NfL), a protein associated with neurodegeneration was also reduced in participants treated with zervimesine compared to placebo. Similarly, amyloid beta (Aβ) and tau species (p-Tau217), which are proteins that build up in patients with Alzheimer’s disease, were lower in participants treated with zervimesine for six months compared to placebo-treated individuals.
“The data that we are presenting at AD/PD this week show that changes in certain proteins correlate to the cognitive effect of zervimesine that we saw in the overall study population,” explained Dr. Hamby. “Just as the cognitive effects were more pronounced in the SHINE low-p-Tau217 subgroup, the impact on biomarkers such as GFAP and NfL was also more pronounced in this patient population. Taken as a whole, these analyses support our understanding of zervimesine’s mechanism of action in impacting disease and point to key biological underpinnings by which zervimesine may elicit its effect.”
| Details of Cognition’s presentation are as follows: | ||
| Title: | 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) | |
| Authors: | Hamby ME, Kavanagh S, Di Caro V, Zetterberg H, Blennow K, Teunissen CE, Grundman M, Caggiano AO | |
| Date/time: | 01 April 2025 at 2:45pm CET | |
| Location: | Hall A | |
| Title: | CSF Proteomic Biomarker Analysis from Phase 2 Study Shine Identified Effects of S2R Modulator CT1812 in Alzheimer’s Disease (ID 2921) | |
| Authors: | Lizama B, Pandey K, Duong D, Seyfried NT, Cho E, Grundman M, Di Caro V, Caggiano AO, Hamby ME | |
| Location: | Poster Hall | |
| Title: | Identification of CSF Proteins That Correlate with Cognitive Outcomes in Participants of Phase 2 Study Shine Evaluating Effects of CT1812 in Patients with Alzheimer's Disease (ID 3119) | |
| Authors: | Lizama B, Pandey K, Duong D, Seyfried NT, Grundman M, Caggiano AO, Hamby ME | |
| Location: | Poster Hall | |
| Title: | Identification of Molecular Correlates with CT1812 Treatment-related Decrease in NfL CSF Levels Connected to Sigma-2 Receptor | |
| Authors: | Di Caro V, Cho E, Lizama B, Pandey K, Duong D, Seyfried NT, Blennow K, Zetterberg H, Grundman M, Caggiano AO, Hamby ME | |
| Location: | Poster Hall | |
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 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
What were the key findings of CGTX's Phase 2 SHINE study for zervimesine in Alzheimer's disease?
How does zervimesine (CT1812) affect Alzheimer's disease biomarkers?
Which patient group showed the strongest response to CGTX's zervimesine in the SHINE study?
What biomarker presentations did CGTX make at the AD/PD 2025 Conference?
