FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs
15 Octubre 2024 - 7:00AM
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
Annovis Bio (AMEX:ANVS)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
Annovis Bio (AMEX:ANVS)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025