Annovis Announces First Patients Entered into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer’s Disease
Annovis Bio (NYSE: ANVS) has initiated its pivotal Phase 3 study of buntanetap for early Alzheimer's disease (AD) with the enrollment of the first two patients. The randomized, placebo-controlled, double-blind study will evaluate the drug's safety and efficacy over 18 months, divided into a 6-month assessment of symptomatic effects and a 12-month evaluation of disease-modifying effects.
The study follows positive Phase 2/3 trial results showing significant cognitive improvement in early AD patients with no safety concerns. The company recently raised $21 million through a public offering to fund the initial 6-month portion, with the remaining 12-month phase expected to be funded through warrant exercises.
The trial will enroll over 750 participants across approximately 100 U.S. sites, with primary outcomes measured using the ADAS-Cog13 subscale for cognition and ADCS-iADL scale for functional ability. The first two sites have begun recruiting in Winter Park, FL and Tom's River, NJ.
Annovis Bio (NYSE: ANVS) ha avviato il suo studio clinico cruciale di Fase 3 su buntanetap per la malattia di Alzheimer (AD) in fase precoce con l'arruolamento dei primi due pazienti. Lo studio randomizzato, controllato con placebo e in doppio cieco valuterà la sicurezza e l'efficacia del farmaco per un periodo di 18 mesi, suddiviso in una valutazione di 6 mesi sugli effetti sintomatici e una valutazione di 12 mesi sugli effetti modificanti la malattia.
Lo studio segue risultati positivi delle prove di Fase 2/3 che mostrano un miglioramento cognitivo significativo nei pazienti con AD precoce senza preoccupazioni per la sicurezza. L'azienda ha recentemente raccolto 21 milioni di dollari attraverso un'offerta pubblica per finanziare la parte iniziale di 6 mesi, mentre la fase rimanente di 12 mesi si prevede venga finanziata attraverso esercizi di warrant.
Il trial arruolerà oltre 750 partecipanti in circa 100 siti negli Stati Uniti, con gli esiti primari misurati utilizzando la sottoscala ADAS-Cog13 per la cognizione e la scala ADCS-iADL per la capacità funzionale. I primi due siti hanno iniziato la reclutamento a Winter Park, FL e Tom's River, NJ.
Annovis Bio (NYSE: ANVS) ha comenzado su estudio clave de Fase 3 sobre buntanetap para la enfermedad de Alzheimer (AD) en etapa temprana con el reclutamiento de los primeros dos pacientes. El estudio, aleatorizado, controlado con placebo y doble ciego, evaluará la seguridad y eficacia del fármaco durante 18 meses, dividido en una evaluación de 6 meses de los efectos sintomáticos y una evaluación de 12 meses de los efectos modificadores de la enfermedad.
El estudio sigue a los resultados positivos de los ensayos de Fase 2/3 que muestran una mejora cognitiva significativa en pacientes con AD temprana sin preocupaciones de seguridad. La compañía recaudó recientemente 21 millones de dólares a través de una oferta pública para financiar la parte inicial de 6 meses, mientras que se espera que la fase restante de 12 meses se financie mediante el ejercicio de warrants.
El ensayo reclutará a más de 750 participantes en aproximadamente 100 sitios en EE. UU., con los resultados primarios medidos utilizando la subescala ADAS-Cog13 para la cognición y la escala ADCS-iADL para la capacidad funcional. Los primeros dos sitios han comenzado el reclutamiento en Winter Park, FL y Tom's River, NJ.
안노비스 바이오 (NYSE: ANVS)는 초기 알츠하이머병 (AD)을 위한 부나타팁의 중요한 3상 연구를 시작하며 첫 두 환자를 등록했습니다. 이 연구는 무작위 배정, 위약 대조, 이중 맹검 방식으로 18개월 동안 약물의 안전성과 효능을 평가합니다. 6개월의 증상 효과 평가와 12개월의 질병 수정 효과 평가로 나누어 진행됩니다.
이 연구는 안전성에 대한 우려 없이 초기 AD 환자에서 유의한 인지 개선을 보여준 2/3상 시험 결과에 이어 진행됩니다. 회사는 초기 6개월 부분을 자금을 조달하기 위해 최근 2천1백만 달러를 공개 발행을 통해 모금하였으며, 나머지 12개월 단계는 워런트 행사로 자금을 조달할 것으로 예상됩니다.
이번 시험은 약 100개의 미국 사이트에서 750명 이상의 참여자를 모집할 예정이며, 주요 결과는 인지에 대한 ADAS-Cog13 하위척도와 기능적 능력에 대한 ADCS-iADL 척도를 사용하여 측정됩니다. 첫 두 사이트는 플로리다주 윈터파크와 뉴저지주 톰스 리버에서 모집을 시작했습니다.
Annovis Bio (NYSE: ANVS) a lancé son étude pivot de Phase 3 sur le buntanetap pour la maladie d'Alzheimer (AD) à un stade précoce avec l'inscription des deux premiers patients. L'étude randomisée, contrôlée par placebo et à double insu évaluera la sécurité et l'efficacité du médicament sur 18 mois, répartis en une évaluation de 6 mois des effets symptomatiques et une évaluation de 12 mois des effets modificateurs de la maladie.
L'étude fait suite à des résultats positifs des essais de Phase 2/3 montrant une amélioration cognitive significative chez les patients atteints d'AD précoce, sans préoccupations de sécurité. La société a récemment levé 21 millions de dollars par le biais d'une offre publique pour financer la première partie de 6 mois, la phase restante de 12 mois devant être financée par l'exercice de bons de souscription.
L'essai recrutera plus de 750 participants sur environ 100 sites aux États-Unis, les résultats primaires étant mesurés à l'aide de la sous-échelle ADAS-Cog13 pour la cognition et de l'échelle ADCS-iADL pour la capacité fonctionnelle. Les deux premiers sites ont commencé le recrutement à Winter Park, FL et Tom's River, NJ.
Annovis Bio (NYSE: ANVS) hat mit seiner entscheidenden Studie der Phase 3 zu Buntanetap für frühe Alzheimer-Krankheit (AD) begonnen und die ersten zwei Patienten eingeschlossen. Die randomisierte, placebokontrollierte, doppelblinde Studie wird die Sicherheit und Wirksamkeit des Medikaments über einen Zeitraum von 18 Monaten bewerten, aufgeteilt in eine 6-monatige Bewertung der symptombedingten Wirkungen und eine 12-monatige Evaluation der krankheitsmodifizierenden Wirkungen.
Die Studie folgt auf positive Ergebnisse der Phase 2/3-Studien, die eine signifikante kognitive Verbesserung bei Patienten mit frühem AD ohne Sicherheitsbedenken zeigen. Das Unternehmen hat kürzlich 21 Millionen Dollar durch ein öffentliches Angebot gesammelt, um die erste 6-monatige Phase zu finanzieren, während die verbleibende 12-monatige Phase voraussichtlich durch die Ausübung von Warrants finanziert wird.
Die Studie wird über 750 Teilnehmer an etwa 100 Standorten in den USA einstellen, wobei die primären Ergebnisse mithilfe der ADAS-Cog13-Unterskala für Kognition und der ADCS-iADL-Skala für die funktionale Fähigkeit gemessen werden. Die ersten beiden Standorte haben mit der Rekrutierung in Winter Park, FL und Tom's River, NJ begonnen.
- Successful initiation of Phase 3 trial following positive Phase 2/3 results
- Secured $21 million in funding through public offering
- Previous trials showed significant cognitive improvement with no safety concerns
- Large-scale study with over 750 participants across 100 sites
- Additional funding needed for 12-month phase, dependent on warrant exercises
- Extended 18-month trial duration may impact time to market
- Significant dilution from public offering of 5,250,000 units
Insights
The initiation of Annovis Bio's Phase 3 trial for buntanetap represents a pivotal moment in Alzheimer's disease treatment development, with several noteworthy strategic elements:
Trial Design Excellence: The innovative dual-phase approach (6-month symptomatic + 12-month disease-modification assessment) demonstrates sophisticated trial design that could provide comprehensive efficacy data. This structure allows for both immediate cognitive benefit evaluation and longer-term disease-modifying effects, potentially strengthening the drug's market position if successful.
Financial Strategy Analysis: The
Market Positioning & Development Timeline: With 750 participants across 100 sites, this robust study size suggests: 1) Strong statistical power for regulatory approval 2) Comprehensive safety data collection 3) Potential completion timeline of 24-30 months, accounting for recruitment and treatment periods. The focus on early AD patients aligns with current therapeutic trends and market demand.
Commercial Implications: Previous Phase 2/3 positive cognitive improvement data, combined with the comprehensive Phase 3 design, positions buntanetap competitively in the AD market. The dual symptomatic/disease-modifying approach could differentiate it from existing treatments, potentially supporting premium pricing and broader market adoption if approved.
MALVERN, Pa., Feb. 05, 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 first two patients have been entered into the pivotal Phase 3 study evaluating buntanetap in early AD.
"The launch of our highly anticipated AD study is a significant milestone in advancing buntanetap toward market approval and addressing the unmet medical need of millions of patients. Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis.
The Phase 3 trial is a randomized, placebo-controlled, double-blind study designed to evaluate the safety and efficacy of a daily dose of buntanetap in patients with early AD. The treatment will last for 18 months and will consist of two parts: a 6-month assessment of symptomatic effects followed by an additional 12-month evaluation of buntanetap’s potential disease-modifying effects. This Phase 3 protocol received FDA approval following positive data from our previous Phase 2/3 trial, which demonstrated significant cognitive improvement in a subgroup of patients with early AD and showed no safety concerns.
The Company has recently completed a public offering of 5,250,000 units consisting of one share of our common stock and one warrant to purchase one share of common stock for gross proceeds of
"Alzheimer’s steals so much from individuals and their families, but with drugs like buntanetap, we aim to restore quality of life and bring hope to those affected. We are grateful to the community for their continuous support and to everyone who has contributed to making this trial a reality. As we embark on this new chapter, we are optimistic that this study will help redefine the future of Alzheimer’s treatment,” adds Melissa Gaines, SVP of Clinical Operations.
The study’s primary outcomes will include the assessment of cognition using the Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) subscale and functional ability using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale.
Annovis anticipates enrolling over 750 participants across ~100 sites in the United States. The first two open sites that began recruiting include Conquest Research in Winter Park, FL and Advanced Memory Research Institute of New Jersey in Tom’s River, NJ, each managed by the dedicated teams of Malisa Agard, M.D. and Arun Singh, D.O., respectively. Detailed information about the trial is available at clinicaltrials.gov.
About Buntanetap
Buntanetap is a small, orally available molecule that targets neurodegeneration by inhibiting the translation of neurotoxic aggregating proteins and thereby impeding the toxic cascade. This improves axonal transport, synaptic transmission, and reduces neuroinflammation, ultimately restoring the health of nerve cells and brain function. By normalizing these pathways, buntanetap has the potential to reverse neurodegeneration and improve quality of life for patients.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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
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