FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
Rhea-AI Summary
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.
Positive
- 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.
Negative
- None.
News Market Reaction 1 Alert
On the day this news was published, ANVS declined 5.61%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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.
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. Additionally, we invite you to explore our updated investor website, which provides comprehensive access to company news, financial reports, and other key information.
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
What is the significance of the FDA accepting Annovis Bio's updated Phase 3 protocol?
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What changes were made to Annovis Bio's Phase 3 Alzheimer's study protocol?
What potential does the 6-month data from Annovis Bio's Phase 3 trial have?
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