Full Press Release Details
Annovis Announces First Patients Entered into Pivotal Phase 3 Study
of Buntanetap for Early Alzheimer's Disease
MALVERN, Pa., Feb. 5, 2025 - 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 $21 million securing
the estimated funding for the initial 6-month portion of the study, while the 12-month phase is expected to be supported by additional
capital from the warrant exercises.
"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.
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.
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing
press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. For more 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.
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