FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs
Annovis Bio Inc. (NYSE: ANVS) has received FDA clearance to proceed with pivotal Phase 3 studies for its Alzheimer's disease (AD) treatment, buntanetap, following a successful End-of-Phase 2 meeting. The FDA's decision is based on Phase 2/3 clinical data showing symptomatic improvement in early AD patients. The Phase 3 program will include two trials: a 6-month study for symptomatic effects and an 18-month study for potential disease-modifying effects.
The FDA raised no concerns about buntanetap's safety data and confirmed that development can proceed using the new crystal form. Annovis aims to file two New Drug Applications (NDAs), one for short-term and one for long-term efficacy. The company plans to initiate the trials early next year, with the possibility of an NDA filing within one year of the 6-month study's start, pending successful execution.
Annovis Bio Inc. (NYSE: ANVS) ha ricevuto l'approvazione dalla FDA per procedere con studi clinici pivotal di Fase 3 per il trattamento dell'Alzheimer, buntanetap, dopo un incontro di successo al termine della Fase 2. La decisione della FDA si basa su dati clinici di Fase 2/3 che mostrano un miglioramento sintomatico nei pazienti con Alzheimer precoce. Il programma di Fase 3 includerà due studi: un studio di 6 mesi per gli effetti sintomatici e un studio di 18 mesi per i potenziali effetti modificatori della malattia.
La FDA non ha sollevato preoccupazioni riguardo ai dati di sicurezza di buntanetap e ha confermato che lo sviluppo può proseguire utilizzando la nuova forma cristallina. Annovis intende presentare due Domande di Nuovo Farmaco (NDA), una per l'efficacia a breve termine e una per l'efficacia a lungo termine. L'azienda prevede di avviare gli studi all'inizio del prossimo anno, con la possibilità di presentare un NDA entro un anno dall'inizio dello studio di 6 mesi, a condizione che l'esecuzione sia riuscita.
Annovis Bio Inc. (NYSE: ANVS) ha recibido la aprobación de la FDA para proceder con estudios pivotal de Fase 3 para su tratamiento de la enfermedad de Alzheimer, buntanetap, tras una exitosa reunión al final de la Fase 2. La decisión de la FDA se basa en datos clínicos de Fase 2/3 que muestran una mejora sintomática en pacientes con Alzheimer temprano. El programa de Fase 3 incluirá dos ensayos: un estudio de 6 meses para efectos sintomáticos y un estudio de 18 meses para posibles efectos modificadores de la enfermedad.
La FDA no expresó preocupaciones sobre los datos de seguridad de buntanetap y confirmó que el desarrollo puede continuar utilizando la nueva forma cristalina. Annovis planea presentar dos Solicitudes de Nuevos Medicamentos (NDA), una para eficacia a corto plazo y otra para eficacia a largo plazo. La empresa tiene la intención de iniciar los ensayos a principios del próximo año, con la posibilidad de presentar un NDA dentro de un año desde el inicio del estudio de 6 meses, siempre que la ejecución sea exitosa.
Annovis Bio Inc. (NYSE: ANVS)는 알츠하이머병(AD) 치료제인 buntanetap의 3상 연구를 진행할 수 있도록 FDA 승인을 받았으며, 이는 2상 종료 회의에서 성공적인 결과를 거둔 후 이루어졌습니다. FDA의 결정은 초기 AD 환자에서 증상 개선을 보여주는 2/3상 임상 데이터를 바탕으로 하고 있습니다. 3상 프로그램에는 증상 효과를 위한 6개월 연구와 질병 변경 가능성을 검토하기 위한 18개월 연구가 포함될 것입니다.
FDA는 buntanetap의 안전성 데이터에 대해 아무런 우려를 제기하지 않았으며 새로운 결정구조를 사용하여 개발을 계속할 수 있다고 확인했습니다. Annovis는 단기 및 장기 효능을 각각 위한 두 개의 신약 신청(NDA)을 제출할 계획이며, 내년 초에 임상을 시작하고 6개월 연구 시작 후 1년 이내에 NDA를 제출할 수 있는 가능성이 있습니다. 다만, 성공적인 실행이 전제조건입니다.
Annovis Bio Inc. (NYSE: ANVS) a reçu l'approbation de la FDA pour procéder à des études de Phase 3 cruciales pour son traitement de la maladie d'Alzheimer, buntanetap, suite à une réunion de fin de Phase 2 réussie. La décision de la FDA est basée sur des données cliniques de Phase 2/3 montrant une amélioration symptomatique chez les patients atteints d'Alzheimer à un stade précoce. Le programme de Phase 3 comportera deux essais : une étude de 6 mois pour les effets symptomatiques et une étude de 18 mois pour évaluer les effets potentiels de modification de la maladie.
La FDA n'a soulevé aucune préoccupation concernant les données de sécurité de buntanetap et a confirmé que le développement pouvait se poursuivre en utilisant la nouvelle forme cristalline. Annovis prévoit de déposer deux demandes de nouveaux médicaments (NDA), une pour l'efficacité à court terme et une pour l'efficacité à long terme. L'entreprise envisage de démarrer les essais début de l'année prochaine, avec la possibilité de déposer une NDA dans l'année suivant le début de l'étude de 6 mois, sous réserve d'une exécution réussie.
Annovis Bio Inc. (NYSE: ANVS) hat die Zustimmung der FDA erhalten, um mit wegweisenden Phase-3-Studien für sein Alzheimer-Krankheit (AD)-Behandlungsprodukt, buntanetap, fortzufahren, nachdem ein erfolgreiches Ende-der-Phase-2-Meeting stattgefunden hat. Die Entscheidung der FDA basiert auf Phase-2/3 klinischen Daten, die eine symptomatische Verbesserung bei frühen AD-Patienten zeigen. Das Phase-3-Programm wird zwei Studien umfassen: eine 6-Monats-Studie zu den symptomatischen Effekten und eine 18-Monats-Studie zu den potenziellen krankheitsmodifizierenden Effekten.
Die FDA äußerte keine Bedenken hinsichtlich der Sicherheitsdaten von buntanetap und bestätigte, dass die Entwicklung mit der neuen Kristallform fortgesetzt werden kann. Annovis plant, zwei Neue Arzneimittelanträge (NDAs) einzureichen, einen für die kurzfristige und einen für die langfristige Wirksamkeit. Das Unternehmen beabsichtigt, die Studien Anfang nächsten Jahres zu starten, mit der Möglichkeit, innerhalb eines Jahres nach Beginn der 6-Monats-Studie einen NDA-Antrag einzureichen, vorbehaltlich einer erfolgreichen Durchführung.
- FDA clearance to proceed with pivotal Phase 3 studies for Alzheimer's treatment
- Positive Phase 2/3 clinical data showing symptomatic improvement in early AD patients
- Potential for expedited NDA filing within one year of 6-month study initiation
- No FDA concerns raised about buntanetap's safety data
- Approval to use new crystal form of buntanetap in development
- None.
Insights
This is a significant milestone for Annovis Bio and the Alzheimer's research field. The FDA's clearance for pivotal Phase 3 studies based on Phase 2/3 data showing symptomatic improvement in early AD patients is highly promising. The two-pronged approach with a 6-month symptomatic study and an 18-month disease-modifying study is strategically sound.
The possibility of filing an NDA based on the 6-month study alone could accelerate the drug's path to market significantly. This is particularly noteworthy given the urgent need for effective Alzheimer's treatments. The FDA's lack of concerns regarding safety data, including liver enzymes and drug interactions, is reassuring and bodes well for the drug's safety profile.
The use of a new crystal form of buntanetap without FDA objection suggests potential improvements in drug delivery or efficacy. Overall, this news positions Annovis favorably in the competitive landscape of Alzheimer's drug development, with a clear regulatory pathway and the potential for relatively rapid market entry.
This FDA clearance is a major catalyst for Annovis Bio, potentially accelerating their timeline to market. The company's market cap of
- Reduced regulatory uncertainty, which could attract more investor interest and partnerships
- Potential for faster revenue generation if the 6-month study leads to NDA approval
- Likely increase in company valuation as it moves closer to commercialization
Investors should note the company's cash position and burn rate, as Phase 3 trials are expensive. However, this news may improve Annovis's ability to raise capital on favorable terms. The dual approach of symptomatic and disease-modifying studies also provides multiple shots on goal, potentially de-risking the investment thesis. Watch for potential licensing deals or partnerships that could further validate the technology and provide non-dilutive funding.
MALVERN, Pa., Oct. 15, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced today the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on October 10, 2024. During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap towards the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy.
The Phase 3 program will investigate buntanetap in patients with early AD and will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month study designed to demonstrate potential disease-modifying effects. While the Company plans to run both studies, the completion of a well-designed and well-executed 6-month trial may be sufficient to support an NDA filing, potentially within one year of the study’s initiation.
Additionally, the FDA raised no concerns about the Company’s data on buntanetap’s safety, including liver enzymes, drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics and confirmed that development can proceed using the new crystal form of buntanetap.
“We are now ready to move into the highly anticipated Phase 3 stage,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio. “Our priority is to bring the treatment to patients as early as possible, and we are committed to ensuring the next clinical trial is executed at the highest standards to attain an expedited NDA submission. Our team is already preparing for trial initiation early next year and will continue to keep you updated as we advance towards our goal.”
About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio Inc. 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:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
www.annovisbio.com/investors-relations
IR@annovisbio.com
FAQ
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