Cassava Sciences Announces Completion of an Interim Safety Review of Oral Simufilam On-going Phase 3 Trials
Cassava Sciences (Nasdaq: SAVA) has announced the completion of a third interim safety review for simufilam in ongoing Phase 3 clinical trials for Alzheimer's disease. An independent Data and Safety Monitoring Board (DSMB) recommended that both Phase 3 studies continue without modification. The company's Chief Medical Officer expressed satisfaction with the safety review and anticipates announcing top-line efficacy, safety, and biomarker data for the 12-month Phase 3 study before the end of 2024.
The Phase 3 program consists of two fully enrolled trials with over 1,900 patients. The first trial (52-week treatment) expects top-line results by year-end 2024, while the second trial (76-week treatment) anticipates results around mid-year 2025. This news follows previous interim safety data suggesting simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA).
Cassava Sciences (Nasdaq: SAVA) ha annunciato il completamento di una terza revisione interinale della sicurezza per simufilam negli attuali studi clinici di Fase 3 per la malattia di Alzheimer. Un Comitato indipendente per il Monitoraggio della Sicurezza dei Dati (DSMB) ha raccomandato che entrambi gli studi di Fase 3 proseguano senza modifiche. Il Chief Medical Officer dell'azienda ha espresso soddisfazione per la revisione della sicurezza e prevede di annunciare i dati principali sull'efficacia, sulla sicurezza e sui biomarcatori per lo studio di Fase 3 di 12 mesi prima della fine del 2024.
Il programma di Fase 3 comprende due studi completamente arruolati con oltre 1.900 pazienti. Il primo studio (trattamento di 52 settimane) prevede di ottenere risultati principali entro la fine del 2024, mentre il secondo studio (trattamento di 76 settimane) anticipa risultati intorno alla metà del 2025. Questa notizia segue i precedenti dati di sicurezza interinale che suggeriscono che simufilam non è associato ad anomalie di imaging correlate all'amiloide emergenti dal trattamento (ARIA).
Cassava Sciences (Nasdaq: SAVA) ha anunciado la finalización de una tercera revisión interina de seguridad para simufilam en ensayos clínicos en Fase 3 en curso para la enfermedad de Alzheimer. Un Consejo Independiente de Monitoreo de Datos y Seguridad (DSMB) recomendó que ambos estudios de Fase 3 continúen sin modificaciones. El Director Médico de la empresa expresó su satisfacción con la revisión de seguridad y anticipa anunciar los datos principales de eficacia, seguridad y biomarcadores para el estudio de Fase 3 de 12 meses antes de finales de 2024.
El programa de Fase 3 consta de dos ensayos completamente reclutados con más de 1,900 pacientes. El primer ensayo (tratamiento de 52 semanas) espera resultados principales para finales de 2024, mientras que el segundo ensayo (tratamiento de 76 semanas) anticipa resultados alrededor de mediados de 2025. Esta noticia sigue a datos de seguridad interina previos que sugieren que simufilam no está asociado con anomalías de imagen relacionadas con amiloides emergentes por el tratamiento (ARIA).
카사바 사이언스(Cassava Sciences)(Nasdaq: SAVA)는 알츠하이머병에 대한 임상 3상 시험에서 시무필람(simufilam)에 대한 세 번째 중간 안전성 검토를 완료했다고 발표했습니다. 독립적인 데이터 및 안전성 모니터링 위원회(DSMB)는 두 개의 3상 연구가 수정 없이 계속 진행될 것을 권장했습니다. 회사의 최고 의료 책임자는 안전성 검토에 대한 만족감을 표명했으며, 2024년 말까지 12개월 3상 연구의 주요 효능, 안전성 및 바이오마커 데이터를 발표할 것으로 예상하고 있습니다.
3상 프로그램은 1,900명 이상의 환자가 등록된 두 개의 완전 등록 시험으로 구성되어 있습니다. 첫 번째 시험(52주 치료)은 2024년 연말까지의 주요 결과를 기대하고 있으며, 두 번째 시험(76주 치료)은 2025년 중반경의 결과를 예상하고 있습니다. 이 소식은 치료에 의해 나타나는 아밀로이드 관련 영상 이상(ARIA)과 시무필람이 관련이 없다는 이전의 중간 안전성 데이터에 따른 것입니다.
Cassava Sciences (Nasdaq: SAVA) a annoncé l'achèvement d'une troisième revue intermédiaire de la sécurité pour simufilam dans le cadre d'essais cliniques de phase 3 en cours pour la maladie d'Alzheimer. Un comité indépendant de surveillance des données et de la sécurité (DSMB) a recommandé que les deux études de phase 3 se poursuivent sans modifications. Le directeur médical de l'entreprise a exprimé sa satisfaction concernant la revue de la sécurité et prévoit d'annoncer les données fondamentales sur l'efficacité, la sécurité et les biomarqueurs pour l'étude de phase 3 de 12 mois avant la fin de 2024.
Le programme de phase 3 comprend deux essais entièrement inscrits avec plus de 1.900 patients. Le premier essai (traitement de 52 semaines) attend des résultats fondamentaux d'ici la fin de 2024, tandis que le deuxième essai (traitement de 76 semaines) prévoit des résultats autour de la mi-2025. Cette nouvelle fait suite à des données intermédiaires de sécurité antérieures suggérant que simufilam n'est pas associé à des anomalies d'imagerie liées aux amyloïdes liées au traitement (ARIA).
Cassava Sciences (Nasdaq: SAVA) hat den Abschluss einer dritten Zwischenprüfung der Sicherheit für Simufilam in laufenden klinischen Studien der Phase 3 zur Alzheimer-Krankheit bekannt gegeben. Ein unabhängiges Daten- und Sicherheitsüberwachungskomitee (DSMB) empfahl, dass beide Phase-3-Studien ohne Änderungen fortgesetzt werden. Der Chief Medical Officer des Unternehmens äußerte Zufriedenheit mit der Sicherheitsprüfung und erwartet, die wichtigen Wirksamkeits-, Sicherheits- und Biomarker-Daten der 12-monatigen Phase-3-Studie vor Ende 2024 bekannt zu geben.
Das Phase-3-Programm besteht aus zwei vollständig rekrutierten Studien mit über 1.900 Patienten. Die erste Studie (52-wöchige Behandlung) erwartet bis Ende 2024 wichtige Ergebnisse, während die zweite Studie (76-wöchige Behandlung) Ergebnisse Mitte 2025 erwartet. Diese Nachricht folgt auf frühere Zwischen-Sicherheitsdaten, die nahelegen, dass Simufilam nicht mit behandlungsbedingten, amiloidbezogenen Bildgebungsanomalien (ARIA) assoziiert ist.
- Independent DSMB recommends continuation of both Phase 3 trials without modification
- Phase 3 trials are fully enrolled with over 1,900 patients
- Top-line results for the 52-week Phase 3 trial expected by year-end 2024
- Previous interim safety data suggests simufilam is not associated with ARIA
- None.
Insights
The completion of the third interim safety review for simufilam in Cassava Sciences' Phase 3 trials is a significant milestone in the drug's development for Alzheimer's disease. The Data and Safety Monitoring Board's recommendation to continue both trials without modification is encouraging for the safety profile of simufilam.
Key points to consider:
- Over 1,900 patients with mild-to-moderate Alzheimer's are enrolled in the two Phase 3 trials.
- Top-line results for the 52-week trial are expected by year-end 2024 and for the 76-week trial by mid-year 2025.
- Previous interim safety data suggested simufilam is not associated with ARIA, a common side effect of some Alzheimer's treatments.
While these safety reviews are promising, it's important to note that efficacy data is still pending. The upcoming top-line results will be critical in determining simufilam's potential as an Alzheimer's treatment. Investors should remain cautious, as many Alzheimer's drugs have shown promise in early stages but failed in late-stage trials.
This news is positive for Cassava Sciences (NASDAQ: SAVA) and could potentially impact its stock performance. Key financial implications include:
- Reduced risk of trial termination due to safety concerns, protecting the company's R&D investment.
- Increased likelihood of completing the Phase 3 trials, bringing simufilam closer to potential FDA approval and commercialization.
- Positive safety profile may enhance simufilam's market potential if efficacy is also demonstrated.
However, investors should note that SAVA, with a market cap of
- An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials.
- The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification.
- Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program.
AUSTIN, Texas, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) resulted in a recommendation that both of Cassava Sciences’ on-going Phase 3 studies continue as planned, without modification.
“We are pleased to have satisfactorily completed this safety review, the last before the expected top-line read out for our first Phase 3 study.” said Jim Kupiec, Chief Medical Officer. “We look forward to announcing top-line efficacy, safety and biomarker data for our 12-month Phase 3 study before the end of 2024.”
The DSMB is composed of independent clinical research experts who periodically review interim patient safety data for Cassava Sciences’ on-going Phase 3 trials of simufilam in Alzheimer’s disease. This DSMB only reviews patient safety. It does not assess drug efficacy.
On-going Phase 3 Studies with Simufilam
Cassava Sciences’ simufilam is a novel, small molecule drug candidate for the proposed treatment of Alzheimer’s disease dementia. The drug is in late-stage clinical evaluation in a pair of pivotal Phase 3 trials. These Phase 3 trials are fully enrolled. Over 1,900 patients with mild-to-moderate Alzheimer’s disease who also met other study eligibility criteria were randomized into the trials.
The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this trial. Top-line results for the 52-week Phase 3 trial are currently expected by year-end 2024.
The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this trial. Top-line results for the 76-week Phase 3 trial are currently expected approximately mid-year 2025.
Patients with mild-to-moderate Alzheimer’s disease dementia who met study eligibility criteria were recruited into the Phase 3 program from clinical sites in the U.S., Puerto Rico, Canada, Australia and South Korea. Cassava Sciences is conducting its on-going Phase 3 program in collaboration with Premier Research International, a global contract research organization (CRO).
Today’s news follows interim safety MRI data announced in October 2023, which suggests simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). In addition, September 2023 and March 2024 meetings of the DSMB recommended that both Phase 3 trials continue as planned, without modification. Final safety data are expected at the conclusion of the Phase 3 program.
About Cassava Sciences, Inc.
Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease.
Simufilam is Cassava Sciences’ small molecule oral drug candidate currently in Phase 3 clinical trials for the treatment of Alzheimer's disease. Simufilam targets a specific site on filamin A, a scaffolding protein that is critical to certain receptor interactions in the brain. Cassava Sciences believes that simufilam interrupts amyloid-β42 binding to receptors in the brain and may affect the Alzheimer's disease process. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party.
For more information, please visit: https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com
Cautionary Note Regarding Forward-Looking Statements and Other Notices:
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning.
Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct, complete or announce top-line results of our clinical studies, including efficacy, safety and biomarker data, on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates in people with Alzheimer’s disease dementia; the interim safety status or profile of simufilam to date in our Phase 3 clinical studies; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; verbal comments made by our employees regarding simufilam, safety, drug effects, and the treatment of Alzheimer’s disease with simufilam; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the period ended June 30, 2024, and future reports to be filed with the SEC.
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All our pharmaceutical assets under development are all investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates are approved or available for sale anywhere in the world, and you should not assume that they may ever be approved or available for sale at any time.
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FAQ
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