Cognition Therapeutics Successfully Passes Pre-defined Futility Analysis of Phase 2 Study of Oral Zervimesine (CT1812) in Geographic Atrophy
Cognition Therapeutics (NASDAQ: CGTX) announced positive results from the futility analysis of its Phase 2 'MAGNIFY' trial for zervimesine (CT1812) in geographic atrophy (GA) secondary to dry age-related macular degeneration.
The analysis of 57 participants who completed 6 months of dosing revealed that zervimesine-treated patients showed slower lesion growth compared to placebo. The study, which enrolled 100 participants total, will conclude in February 2025, with complete analysis expected in Q2 2025.
Additionally, the company reported successful outcomes in other trials: The Phase 2 SHIMMER study in dementia with Lewy bodies (DLB) met its primary endpoint, with zervimesine showing significant improvements over placebo across multiple measures. The Phase 2 SHINE study in Alzheimer's disease also met its safety endpoint, with a biomarker-defined subgroup showing 95% reduction in cognitive decline versus placebo.
Cognition Therapeutics (NASDAQ: CGTX) ha annunciato risultati positivi dall'analisi di inutilità del suo studio di Fase 2 'MAGNIFY' per zervimesine (CT1812) nell'atrofia geografica (GA) secondaria alla degenerazione maculare legata all'età secca.
L'analisi di 57 partecipanti che hanno completato 6 mesi di trattamento ha rivelato che i pazienti trattati con zervimesine hanno mostrato una crescita delle lesioni più lenta rispetto al placebo. Lo studio, che ha arruolato un totale di 100 partecipanti, si concluderà a febbraio 2025, con un'analisi completa prevista per il secondo trimestre del 2025.
Inoltre, l'azienda ha riportato risultati positivi in altri studi: lo studio di Fase 2 SHIMMER nella demenza con corpi di Lewy (DLB) ha raggiunto il suo obiettivo primario, con zervimesine che ha mostrato miglioramenti significativi rispetto al placebo su più misure. Anche lo studio di Fase 2 SHINE nella malattia di Alzheimer ha raggiunto il suo obiettivo di sicurezza, con un sottogruppo definito da biomarker che ha mostrato una riduzione del 95% nel declino cognitivo rispetto al placebo.
Cognition Therapeutics (NASDAQ: CGTX) anunció resultados positivos del análisis de inutilidad de su ensayo de Fase 2 'MAGNIFY' para zervimesina (CT1812) en atrofia geográfica (GA) secundaria a la degeneración macular relacionada con la edad seca.
El análisis de 57 participantes que completaron 6 meses de tratamiento reveló que los pacientes tratados con zervimesina mostraron un crecimiento más lento de las lesiones en comparación con el placebo. El estudio, que inscribió un total de 100 participantes, concluirá en febrero de 2025, con un análisis completo esperado para el segundo trimestre de 2025.
Además, la empresa reportó resultados exitosos en otros ensayos: el estudio de Fase 2 SHIMMER en demencia con cuerpos de Lewy (DLB) alcanzó su objetivo primario, con zervimesina mostrando mejoras significativas sobre el placebo en múltiples medidas. El estudio de Fase 2 SHINE en la enfermedad de Alzheimer también cumplió con su objetivo de seguridad, con un subgrupo definido por biomarcadores que mostró una reducción del 95% en el declive cognitivo en comparación con el placebo.
Cognition Therapeutics (NASDAQ: CGTX)는 zervimesine (CT1812)의 건성 노인성 황반변성으로 인한 지리적 위축(GA)에 대한 2상 'MAGNIFY' 시험의 무용성 분석에서 긍정적인 결과를 발표했습니다.
6개월 동안 치료를 받은 57명의 참가자 분석 결과, zervimesine 치료를 받은 환자들이 위약에 비해 병변 성장 속도가 느린 것으로 나타났습니다. 총 100명의 참가자가 등록된 이 연구는 2025년 2월에 종료될 예정이며, 2025년 2분기에 전체 분석이 예상됩니다.
또한, 이 회사는 다른 시험에서 성공적인 결과를 보고했습니다: 루이체 치매(DLB)에 대한 2상 SHIMMER 연구는 주요 목표를 달성했으며, zervimesine이 여러 측정에서 위약에 비해 상당한 개선을 보였습니다. 알츠하이머병에 대한 2상 SHINE 연구도 안전성 목표를 달성했으며, 바이오마커로 정의된 하위 그룹이 위약에 비해 인지 감소가 95% 감소한 것으로 나타났습니다.
Cognition Therapeutics (NASDAQ: CGTX) a annoncé des résultats positifs de l'analyse d'inutilité de son essai de Phase 2 'MAGNIFY' pour zervimesine (CT1812) dans l'atrophie géographique (GA) secondaire à la dégénérescence maculaire liée à l'âge sèche.
L'analyse de 57 participants ayant complété 6 mois de traitement a révélé que les patients traités par zervimesine présentaient une croissance des lésions plus lente par rapport au placebo. L'étude, qui a inclus un total de 100 participants, se terminera en février 2025, avec une analyse complète prévue pour le deuxième trimestre de 2025.
De plus, la société a rapporté des résultats positifs dans d'autres essais : l'étude de Phase 2 SHIMMER dans la démence à corps de Lewy (DLB) a atteint son objectif principal, avec zervimesine montrant des améliorations significatives par rapport au placebo sur plusieurs mesures. L'étude de Phase 2 SHINE dans la maladie d'Alzheimer a également atteint son objectif de sécurité, avec un sous-groupe défini par biomarqueur montrant une réduction de 95% du déclin cognitif par rapport au placebo.
Cognition Therapeutics (NASDAQ: CGTX) gab positive Ergebnisse aus der Nutzlosigkeitsanalyse seiner Phase-2-Studie 'MAGNIFY' für zervimesin (CT1812) bei geografischer Atrophie (GA) sekundär zur trockenen altersbedingten Makuladegeneration bekannt.
Die Analyse von 57 Teilnehmern, die 6 Monate lang behandelt wurden, ergab, dass Patienten, die mit zervimesin behandelt wurden, ein langsameres Wachstum der Läsionen im Vergleich zur Placebo-Gruppe zeigten. Die Studie, an der insgesamt 100 Teilnehmer teilnahmen, wird im Februar 2025 abgeschlossen, mit einer vollständigen Analyse, die im 2. Quartal 2025 erwartet wird.
Darüber hinaus berichtete das Unternehmen von erfolgreichen Ergebnissen in anderen Studien: Die Phase-2-Studie SHIMMER bei Demenz mit Lewy-Körpern (DLB) erreichte ihr primäres Ziel, wobei zervimesin signifikante Verbesserungen gegenüber dem Placebo in mehreren Messungen zeigte. Die Phase-2-Studie SHINE bei Alzheimer-Krankheit erfüllte ebenfalls ihr Sicherheitsziel, wobei eine biomarker-definierte Untergruppe eine Reduktion von 95% im kognitiven Rückgang im Vergleich zum Placebo zeigte.
- Positive futility analysis showing slower lesion growth in GA patients
- SHIMMER study met primary endpoint with strong efficacy metrics
- SHINE study showed 95% reduction in cognitive decline in specific subgroup
- Multiple successful Phase 2 trials across different indications
- Advancing to FDA discussions for registrational studies
- Early termination of MAGNIFY study to preserve financial resources
Insights
Cognition Therapeutics has reported promising efficacy signals from its Phase 2 MAGNIFY trial of oral zervimesine in geographic atrophy (GA), showing slower lesion growth in treated patients versus placebo after 6 months. Despite these positive signals, the company has strategically decided to conclude the study early while preserving the ability to generate 12-month data, with full results expected in Q2 2025.
The company's decision to reallocate resources away from ophthalmology despite positive signals appears driven by even stronger results in their CNS programs and the need to conserve capital. With a micro-cap valuation of just
Their DLB program shows particularly compelling efficacy signals, with improvements of
The consistent positive signals across multiple neurodegenerative conditions suggest zervimesine may have a fundamental mechanism of action targeting common pathological processes. This multi-indication potential significantly enhances the compound's value proposition, as success in any one indication could support development across others.
The planned FDA meetings to discuss registrational trial designs represent a critical inflection point that could accelerate the path to potential approval in both Alzheimer's and DLB, conditions with substantial unmet needs and commercial potential far exceeding that of GA.
Cognition's strategic decision to conclude the GA study despite positive signals represents astute capital allocation for a company with resources (
The DLB indication is particularly compelling from an investment perspective. The
Similarly, the Alzheimer's data showing
This pipeline prioritization extends Cognition's cash runway while focusing on indications with the strongest signals, effectively derisking their development program. The consistent positive data across multiple neurodegenerative conditions is exceedingly rare for small biotechs and suggests their sigma-2 receptor modulation approach may address fundamental disease mechanisms.
The upcoming FDA end-of-Phase 2 meetings could catalyze significant value creation by potentially streamlining the path to registration trials. For investors, this strategic focus transforms Cognition from a single-bet ophthalmology play into a multi-indication CNS platform company with multiple shots on goal, substantially improving the risk/reward profile despite its micro-cap status.
Masked Analysis Shows Participants Receiving Oral Zervimesine for at Least 6 Months Experienced Slower Lesion Growth than Participants Receiving Placebo
Following the Futility Analysis, Management Concluded the Phase 2 Study, Preserving Capital
Full Analysis will be Provided in the Second Quarter of 2025
PURCHASE, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, reported a positive outcome of an analysis of masked data from the ongoing ‘MAGNIFY’ Phase 2 trial of zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The purpose of this type of analysis, known as a “futility analysis” is to determine if a drug candidate is showing signals of efficacy. Cognition’s contract research organization conducted the analysis to protect the integrity of the clinical trial.
Results of the futility analysis from the first 57 participants who completed at least 6 months of dosing showed that zervimesine-treated patients were experiencing a slower lesion growth rate than those on placebo.
To date, the MAGNIFY study (NCT05893537) has enrolled 100 participants. All participants are completing a final clinic visit in February 2025. Cognition intends to unblind the study at the end of February and provide a complete analysis of the study, including 12 months of dosing, in the second quarter of 2025.
The Company continues to believe that zervimesine has the potential to alter the biological processes that contribute to dry AMD. Cognition and collaborators have generated compelling preclinical evidence to support this. As previously reported, concluding the MAGNIFY study early enabled the Company to preserve financial resources, which will be redeployed to other indications.
In December 2024, Cognition reported that the Phase 2 SHIMMER study in mild-to-moderate dementia with Lewy bodies (DLB) met its primary endpoint of safety and tolerability. In the DLB study, zervimesine-treated participants performed an average of
About Zervimesine (CT1812)
Zervimesine (CT1812) is an investigational oral, once-daily pill being developed 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.
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 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, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our expected runway, 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, the timing of any regulatory interactions and submissions, and expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials 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; impacts of ongoing global and region 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
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