FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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.
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 latest FDA approval for Annovis Bio (ANVS) regarding Alzheimer's treatment?
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