Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer鈥檚 Disease
Cognition Therapeutics (NASDAQ: CGTX) has received FDA confirmation for its Phase 3 program design for zervimesine (CT1812) in Alzheimer's disease treatment. The FDA agreed that two six-month Phase 3 studies could support a New Drug Application (NDA).
The Phase 3 trials will focus on adults with mild-to-moderate Alzheimer's who have lower p-tau217 levels. Previous Phase 2 "SHINE" study showed that zervimesine achieved a 95% reduction in cognitive decline compared to placebo in this population. The studies will randomize participants to receive either 100mg daily oral zervimesine or placebo, with participants eligible for an open-label extension study upon completion.
Cognition Therapeutics (NASDAQ: CGTX) ha ottenuto la conferma dalla FDA sul design del suo programma di Fase 3 per zervimesine (CT1812) nel trattamento della malattia di Alzheimer. L'agenzia ha concordato che due studi di Fase 3 della durata di sei mesi potrebbero supportare una New Drug Application (NDA).
Le sperimentazioni di Fase 3 si concentreranno su adulti con Alzheimer da lieve a moderato che presentano bassi livelli di p-tau217. Il precedente studio di Fase 2 'SHINE' ha mostrato che zervimesine ha ottenuto una riduzione del 95% del declino cognitivo rispetto al placebo in questa popolazione. Gli studi randomizzeranno i partecipanti a ricevere 100 mg al giorno di zervimesine per via orale o placebo, con la possibilit脿 di accedere a uno studio di estensione in aperto al termine.
Cognition Therapeutics (NASDAQ: CGTX) ha recibido la confirmaci贸n de la FDA sobre el dise帽o de su programa de Fase 3 para zervimesine (CT1812) en el tratamiento de la enfermedad de Alzheimer. La FDA acord贸 que dos estudios de Fase 3 de seis meses podr铆an respaldar una New Drug Application (NDA).
Los ensayos de Fase 3 se centrar谩n en adultos con Alzheimer leve a moderado que presenten niveles bajos de p-tau217. El previo estudio de Fase 2 'SHINE' mostr贸 que zervimesine logr贸 una reducci贸n del 95% en el deterioro cognitivo frente a placebo en esta poblaci贸n. Los estudios aleatorizar谩n a los participantes para recibir 100 mg diarios de zervimesine oral o placebo, con opci贸n de participar en un estudio de extensi贸n abierto al finalizar.
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Cognition Therapeutics (NASDAQ: CGTX) a re莽u la confirmation de la FDA concernant le design de son programme de phase 3 pour zervimesine (CT1812) dans le traitement de la maladie d'Alzheimer. La FDA a convenu que deux essais de phase 3 d'une dur茅e de six mois pourraient 茅tayer une New Drug Application (NDA).
Les essais de phase 3 porteront sur des adultes atteints d'Alzheimer l茅ger 脿 mod茅r茅 pr茅sentant de faibles taux de p-tau217. L'茅tude de phase 2 pr茅c茅dente 'SHINE' a montr茅 que zervimesine entra卯nait une r茅duction de 95 % du d茅clin cognitif par rapport au placebo dans cette population. Les 茅tudes randomiseront les participants pour recevoir soit 100 mg par jour de zervimesine orale, soit un placebo, avec la possibilit茅 d'une extension en ouvert 脿 l'issue.
Cognition Therapeutics (NASDAQ: CGTX) hat von der FDA eine Best盲tigung f眉r das Design seines Phase-3-Programms f眉r zervimesine (CT1812) in der Behandlung der Alzheimer-Krankheit erhalten. Die FDA stimmte zu, dass zwei sechsmonatige Phase-3-Studien eine New Drug Application (NDA) unterst眉tzen k枚nnten.
Die Phase-3-Studien werden sich auf Erwachsene mit leichter bis mittelschwerer Alzheimer-Erkrankung mit niedrigen p-tau217-Werten konzentrieren. Die fr眉here Phase-2-Studie 'SHINE' zeigte, dass zervimesine in dieser Patientengruppe den kognitiven Abbau im Vergleich zu Placebo um 95 % reduzierte. Die Studien werden die Teilnehmer randomisieren, entweder 100 mg t盲glich oral verabreichtes zervimesine oder Placebo zu erhalten; nach Abschluss k枚nnen die Teilnehmer an einer offenen Verl盲ngerungsstudie teilnehmen.
- Phase 2 'SHINE' study demonstrated 95% reduction in cognitive decline with zervimesine
- FDA agreed that two 6-month Phase 3 studies could support NDA filing, enabling faster enrollment and earlier regulatory submission
- P-tau217 biomarker screening via blood test simplifies patient selection and may increase study power while reducing costs
- Alignment with FDA on key Phase 3 program elements including enrichment strategy, duration, and endpoints
- Drug efficacy limited to specific patient subset with lower p-tau217 levels
- Full Phase 3 studies still required before potential approval
Insights
FDA confirms Phase 3 path for Cognition's Alzheimer's drug zervimesine, with targeted patient selection potentially offering 95% slowing of cognitive decline.
Cognition Therapeutics has achieved a crucial regulatory milestone with the FDA confirming their proposed Phase 3 program design for zervimesine (CT1812) in Alzheimer's disease. This alignment significantly derisks their development pathway toward a potential New Drug Application (NDA).
The FDA has endorsed Cognition's novel biomarker-driven enrollment strategy, which will focus on mild-to-moderate Alzheimer's patients with lower plasma p-tau217 levels. This is particularly significant because previous Phase 2 "SHINE" study data demonstrated that zervimesine produced a remarkable
The regulatory agency's acceptance of two six-month Phase 3 studies rather than the traditional 12-18 month trials represents a substantial acceleration of the development timeline. This compressed timeline could significantly reduce development costs and bring the drug to market years earlier than the conventional pathway.
The use of p-tau217 as a blood-based biomarker for patient selection represents an important advancement in Alzheimer's clinical trials. Unlike complicated PET scans or lumbar punctures, this simple blood test reduces patient burden while potentially increasing trial statistical power through population enrichment.
This regulatory clarity creates a well-defined path to potential approval for zervimesine, an oral therapy targeting a disease with limited treatment options, positioning Cognition favorably in the competitive Alzheimer's treatment landscape.
- Cognition and FDA align on enriched population, study design, and endpoints -
PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- , (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of-Phase 2 meeting that was conducted on July 9, 2025. FDA confirmed the proposed design of the Phase 3 program may support a New Drug Application (NDA) filing for zervimesine (CT1812) as a treatment for Alzheimer鈥檚 disease.
Based on the FDA鈥檚 feedback, the Phase 3 program is expected to enroll adults with a diagnosis of mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening. * has shown that zervimesine can arrest cognitive deterioration in this population by
鈥淚n the meeting minutes, FDA concurred with our plan to enrich the Phase 3 study population with Alzheimer鈥檚 patients who have lower p-tau217,鈥� stated , Cognition鈥檚 CMO and head of R&D. 鈥淏ecause p-tau217 can be measured by a simple blood test, we expect this strategy will ease the burden on patients. This enrichment strategy may increase the power of the study and reduce trial costs.鈥澨�
Participants will be randomized to either 100mg of oral zervimesine or placebo daily for six months.听Efficacy and safety will be assessed, with endpoints affirmed by the FDA in the meeting minutes. Cognition also plans to include biomarker and imaging assessments in the Phase 3 program to support the clinical outcomes. Participants who complete either study will be eligible to enroll in an open-label extension study.
鈥淏ased on the end-of-Phase 2 meeting minutes, we are aligned with the FDA on a registrational plan for zervimesine that includes details of study enrichment, treatment duration, endpoints, and availability of an open-label extension,鈥� stated , president and CEO of Cognition. 鈥淥ne of the most important outcomes from the meeting was the FDA鈥檚 view that two six-month Phase 3 studies could support a new drug application for zervimesine. This plan allows us to enroll faster, more cost-effective studies, and brings us to a regulatory filing sooner. We look forward to continuing our dialogue with the FDA as we propel zervimesine forward.鈥�
* Results from the Phase 2 鈥淪HINE鈥� study in mild-to-moderate Alzheimer鈥檚 disease showed that participants treated with zervimesine who had lower plasma p-tau217 levels experienced a
About Zervimesine (CT1812)
(CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer鈥檚 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 鈥� A尾 and 蓱-synuclein. As these proteins bind to receptors on the surface of neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person鈥檚 ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. Zervimesine has been shown to interrupt the toxic effects of A尾 and 蓱-synuclein, which may slow progression of disease and improve the lives of those suffering from Alzheimer鈥檚 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 the SHINE Study
The was a double-blind, placebo-controlled Phase 2 study that enrolled 153 adults with mild-to-moderate Alzheimer鈥檚 disease. The study met its primary endpoints of safety and tolerability. Changes in cognition (ADAS-Cog 11, cognitive composite and MMSE) and function (ADCS-ADL and ADCS-CGIC) were also measured. Participants were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months.
The SHINE Study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately
About Cognition Therapeutics, Inc.听听
, 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鈥檚 disease and geographic atrophy secondary to dry AMD. The Phase 2 START study () in early Alzheimer鈥檚 disease is ongoing with
Forward-Looking Statements听
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, as well as statements regarding our regulatory plans, including our end-of-Phase 2 meeting, and our designs and plans for our Phase 3 program, 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 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渁im,鈥� 鈥渟eek,鈥� 鈥渁nticipate,鈥� 鈥渃ould,鈥� 鈥渋ntend,鈥� 鈥渢arget,鈥� 鈥減roject,鈥� 鈥渃ontemplate,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥減redict,鈥� 鈥渇orecast,鈥� 鈥減otential鈥� or 鈥渃ontinue鈥� 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 鈥淩isk Factors鈥� section of our annual and quarterly reports filed with the听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:听听听 Cognition Therapeutics, Inc.听 听听 [email protected]听听 | Mike Moyer (investors)听 LifeSci Advisors听 [email protected]听听 听 |
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FAQ
What did the FDA agree to regarding Cognition Therapeutics' (CGTX) zervimesine Phase 3 trials?
How effective was zervimesine in the Phase 2 SHINE study for Alzheimer's disease?
What is the dosing protocol for CGTX's zervimesine in the Phase 3 Alzheimer's trials?
How will Cognition Therapeutics select patients for the zervimesine Phase 3 trials?
What are the advantages of CGTX's p-tau217 screening approach for the zervimesine trials?
