FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
Annovis Bio (NYSE: ANVS) announced that the FDA has accepted an updated protocol for its pivotal Phase 3 Alzheimer's Disease (AD) study, set to begin in January 2025. The revised protocol integrates two separate trials into a single 6/18-month trial. The original design included a 6-month symptomatic study and an 18-month disease-modifying study. Now, the consolidated protocol features a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment for disease-modifying potential.
In October 2024, the FDA granted clearance for Annovis to proceed based on Phase 2/3 data showing cognitive improvement in early-stage AD patients. According to Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, this streamlined approach will accelerate the development timeline while maintaining scientific rigor. The 6-month symptomatic data could potentially support a New Drug Application (NDA) filing, continuing seamlessly to evaluate long-term outcomes.
This development marks a significant step in advancing buntanetap as a novel treatment for AD, bringing the company closer to delivering new therapeutic options for patients.
Annovis Bio (NYSE: ANVS) ha annunciato che la FDA ha accettato un protocollo aggiornato per il suo studio principale di Fase 3 sulla malattia di Alzheimer (AD), che inizierà a gennaio 2025. Il protocollo rivisto integra due studi separati in un unico studio di 6/18 mesi. Il design originale prevedeva uno studio sintomatico di 6 mesi e uno studio modificante la malattia di 18 mesi. Ora, il protocollo consolidato prevede un'analisi dei dati di 6 mesi incentrata sugli effetti sintomatici, seguita da una valutazione aggiuntiva di 12 mesi per il potenziale modificante la malattia.
Ad ottobre 2024, la FDA ha concesso l'autorizzazione ad Annovis di procedere sulla base dei dati di Fase 2/3 che mostrano miglioramenti cognitivi in pazienti con AD nelle prime fasi. Secondo Maria Maccecchini, Ph.D., Fondatrice, Presidente e CEO di Annovis, questo approccio semplificato accelererà la tempistica di sviluppo mantenendo rigorosità scientifica. I dati sintomatici di 6 mesi potrebbero potenzialmente supportare una domanda di nuovo farmaco (NDA), continuando senza soluzioni di continuità a valutare gli esiti a lungo termine.
Questo sviluppo segna un passo significativo nell'avanzamento di buntanetap come trattamento innovativo per l'AD, avvicinando l'azienda alla possibilità di offrire nuove opzioni terapeutiche per i pazienti.
Annovis Bio (NYSE: ANVS) anunció que la FDA ha aceptado un protocolo actualizado para su estudio pivotal de Fase 3 de la enfermedad de Alzheimer (AD), que comenzará en enero de 2025. El protocolo revisado integra dos ensayos separados en un único ensayo de 6/18 meses. El diseño original incluía un estudio sintomático de 6 meses y un estudio modificador de la enfermedad de 18 meses. Ahora, el protocolo consolidado cuenta con una lectura de datos de 6 meses centrada en los efectos sintomáticos, seguida de una evaluación adicional de 12 meses para el potencial modificador de la enfermedad.
En octubre de 2024, la FDA otorgó la aprobación a Annovis para proceder según los datos de Fase 2/3 que muestran mejoras cognitivas en pacientes con AD en etapas iniciales. Según Maria Maccecchini, Ph.D., Fundadora, Presidenta y CEO de Annovis, este enfoque simplificado acelerará el cronograma de desarrollo mientras mantiene un rigor científico. Los datos sintomáticos de 6 meses podrían potencialmente respaldar una solicitud de nuevo medicamento (NDA), continuando sin interrupciones para evaluar los resultados a largo plazo.
Este desarrollo marca un paso significativo en el avance de buntanetap como un tratamiento novedoso para la AD, acercando a la empresa a ofrecer nuevas opciones terapéuticas para los pacientes.
Annovis Bio (NYSE: ANVS)는 FDA가 2025년 1월에 시작될 예정인 주요 3상 알츠하이머병(AD) 연구를 위한 업데이트된 프로토콜을 수용했다고 발표했습니다. 수정된 프로토콜은 두 개의 개별 시험을 단일 6/18개월 시험으로 통합합니다. 원래 설계는 6개월의 증상 연구와 18개월의 질병 수정 연구를 포함했습니다. 이제 통합된 프로토콜은 증상 효과에 초점을 맞춘 6개월 데이터 리딩을 특징으로 하며, 이어서 질병 수정 가능성을 평가하기 위해 추가 12개월의 평가가 이루어집니다.
2024년 10월, FDA는 Annovis가 초기 단계 AD 환자에서 인지 개선을 보여주는 2/3상 데이터에 기반하여 진행할 수 있도록 승인했습니다. Maria Maccecchini 박사, Annovis의 창립자, 회장 및 CEO에 따르면, 이 단순화된 접근 방식은 과학적 엄격성을 유지하면서 개발 일정을 가속화할 것입니다. 6개월 증상 데이터는 새로운 약물 신청(NDA) 제출을 지원할 수 있으며, 장기 결과를 평가하는 과정도 원활하게 진행될 수 있습니다.
이 개발은 buntanetap이 AD에 대한 새로운 치료제로 발전하는 데 중요한 단계를 의미하며, 회사가 환자에게 새로운 치료 옵션을 제공하는 데 한 걸음 더 가까워졌습니다.
Annovis Bio (NYSE: ANVS) a annoncé que la FDA a accepté un protocole mis à jour pour son étude pivot de Phase 3 sur la maladie d'Alzheimer (AD), qui doit commencer en janvier 2025. Le protocole révisé intègre deux essais distincts en un seul essai de 6/18 mois. Le design initial comprenait une étude symptomatique de 6 mois et une étude modifiant la maladie de 18 mois. Désormais, le protocole consolidé comprend une lecture des données de 6 mois axée sur les effets symptomatiques, suivie d'une évaluation supplémentaire de 12 mois pour le potentiel modifiant la maladie.
En octobre 2024, la FDA a accordé à Annovis l'autorisation de procéder sur la base des données de Phase 2/3 montrant une amélioration cognitive chez les patients AD à un stade précoce. Selon Maria Maccecchini, Ph.D., Fondatrice, Présidente et Directrice Générale d'Annovis, cette approche simplifiée accélérera le calendrier de développement tout en maintenant un rigueur scientifique. Les données symptomatiques de 6 mois pourraient potentiellement soutenir une demande de nouveau médicament (NDA), en continuant sans interruption à évaluer les résultats à long terme.
Ce développement constitue une étape significative dans l'avancement de buntanetap en tant que traitement novateur pour l'AD, rapprochant l'entreprise de la fourniture de nouvelles options thérapeutiques pour les patients.
Annovis Bio (NYSE: ANVS) gab bekannt, dass die FDA ein aktualisiertes Protokoll für seine entscheidende Phase-3-Studie zur Alzheimer-Krankheit (AD) akzeptiert hat, die im Januar 2025 beginnen soll. Das angepasste Protokoll integriert zwei separate Studien zu einer einzigen 6/18-monatigen Studie. Das ursprüngliche Design umfasste eine 6-monatige symptomatische Studie und eine 18-monatige krankheitsmodifizierende Studie. Nun bietet das konsolidierte Protokoll eine 6-monatige Datenanalyse mit Schwerpunkt auf den symptomatischen Effekten, gefolgt von einer zusätzlichen 12-monatigen Bewertung des krankheitsmodifizierenden Potenzials.
Im Oktober 2024 genehmigte die FDA, dass Annovis basierend auf Daten der Phase 2/3 fortfahren kann, die eine kognitive Verbesserung bei Patienten im frühen Stadium von AD zeigen. Laut Maria Maccecchini, Ph.D., Gründerin, Präsidentin und CEO von Annovis, wird dieser vereinfachte Ansatz den Entwicklungszeitplan beschleunigen und gleichzeitig wissenschaftliche Strenge wahren. Die 6-monatigen symptomatischen Daten könnten potenziell eine Einreichung eines Antrags auf Neue Arzneimittel (NDA) unterstützen und nahtlos fortfahren, um die langfristigen Ergebnisse zu bewerten.
Diese Entwicklung stellt einen bedeutenden Schritt in der Weiterentwicklung von buntanetap als neuartige Behandlung für AD dar und bringt das Unternehmen näher daran, neue therapeutische Optionen für Patienten anzubieten.
- FDA acceptance of updated Phase 3 protocol accelerates development timeline.
- Integration of 6-month symptomatic and 18-month disease-modifying studies into a single trial.
- Potential for 6-month data to support a New Drug Application (NDA) filing.
- None.
Insights
From a competitive standpoint, this streamlined approach could give Annovis an edge in the crowded AD therapeutic landscape. The ability to potentially secure approval based on symptomatic benefits while building evidence for disease modification creates a compelling commercial narrative.
The key value inflection points now include: 1) trial initiation in January 2025, 2) 6-month data readout expected in Q3 2025 and 3) potential NDA filing in 2026. This creates a more compressed timeline for value creation compared to the original two-trial approach. The regulatory acceptance also validates the strength of Phase 2/3 data and increases the probability of technical success for the Phase 3 program. For investors, this represents a clearer path to potential value realization with reduced clinical development risk.
MALVERN, Pa., Jan. 07, 2025 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025.
In October 2024, the FDA granted clearance for Annovis to proceed with the pivotal Phase 3 AD studies based on its Phase 2/3 data demonstrating cognitive improvement in early-stage AD patients. The original protocol design proposed two separate trials: a 6-month symptomatic study and an 18-month disease-modifying study. Under the revised protocol, these studies are now integrated into a single 6/18-month trial, which will include a 6-month data readout focused on symptomatic effects, followed by an additional 12-month assessment to evaluate the disease-modifying potential of buntanetap.
“This consolidated protocol will accelerate the development timeline while maintaining the scientific rigor necessary to advance buntanetap as a treatment for AD,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “With this design, we can leverage the 6-month symptomatic data to potentially support a New Drug Application (NDA) filing, all while continuing the same study seamlessly to assess long-term disease-modifying outcomes. We are excited to move forward with this approach, which brings us closer to delivering a novel treatment to patients in need.”
About Annovis Bio
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The company’s innovative approach targets multiple neurotoxic proteins, aiming to restore brain function and improve the quality of life for patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, the Company's plans related to clinical trials. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, but are not limited to, those related to patient enrollment, the effectiveness of Buntanetap, and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety, and tolerability of Buntanetap. Additional risk factors are detailed in the Company's periodic filings with the SEC, including those listed in the "Risk Factors" section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements in this press release are based on information available to the Company as of the date of this release. The Company expressly disclaims any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Contact Information:
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Malvern, PA 19355
www.annovisbio.com
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FAQ
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