Annovis Bio Announces Last Patient Last Visit in the Phase II/III Study of Buntanetap in Alzheimer’s Disease

Rhea-AI Summary

Annovis Bio, Inc. completes phase II/III study for Alzheimer's drug candidate buntanetap with promising results.

Financial Analyst

The announcement by Annovis Bio regarding the completion of their phase II/III clinical trial for buntanetap represents a pivotal moment for the company's valuation and investor sentiment. The successful conclusion of the trial with a high retention rate of 327 out of 353 patients suggests operational efficiency and potential for a strong dataset. Investors should monitor the upcoming results closely as positive data could significantly enhance the company's market position and lead to an upward revision of revenue projections. On the other hand, any setbacks in the data could adversely affect the stock price due to the high stakes associated with drug development in the neurodegenerative space.

Medical Research Analyst

From a medical research perspective, the successful completion of a phase II/III clinical trial for a novel Alzheimer's therapy is noteworthy. Buntanetap's progress could mark a substantial advancement in a field that has seen limited innovation over the past decade. The minimal dropout rate reported enhances the credibility of the study, suggesting robust patient adherence and manageable safety profile. The medical community will be looking for efficacy data, safety outcomes and the drug's mechanism of action in comparison to existing treatments. If buntanetap's results are favorable, it could address a significant unmet need in Alzheimer's care, potentially leading to expedited regulatory review and a swift path to market.

Market Research Analyst

Alzheimer's disease represents a large and growing market, with a global prevalence that is expected to escalate as populations age. The entry of a new therapeutic agent like buntanetap can disrupt the current market dynamics, which is dominated by symptomatic treatments with limited efficacy. A successful new treatment option could not only provide clinical benefits but also bring substantial economic implications due to the high cost burden of Alzheimer's disease. Market analysts will be evaluating the potential market penetration strategies, pricing and reimbursement scenarios for buntanetap, as well as its impact on the competitive landscape. In anticipation of the trial results, stakeholders should assess the potential for Annovis Bio to secure partnerships or attract acquisition interest from larger pharmaceutical companies.

MALVERN, Pa., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases today announced last patient last visit in the phase II/III study of its lead candidate buntanetap in patients with mild to moderate Alzheimer’s disease (AD). 

"The completion of the Alzheimer’s study marks a significant step in our efforts to bring new therapies to patients,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. “The study progressed as intended with minimal dropout rate."

A total of 327 patients have successfully concluded the phase II/III trial out of the initial 353 enrolled.

"The team is now fully focused on meticulously cleaning and analyzing the data, aiming to deliver results in a timely manner," said Melissa Gaines, Senior Vice President, Clinical Operations.

About the Phase II/III Trial
The phase II/III study is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap in patients with mild to moderate AD. This is a dose ranging study where patients receive either one of three doses of buntanetap (7.5mg, 15mg, or 30mg) or placebo on top of their standard of care for 12 weeks. In this study, over 700 patients were screened and a total of 353 patients enrolled across 54 sites in the United States.

About Buntanetap
Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by inhibiting the formation of multiple neurotoxic proteins - amyloid beta, tau, alpha synuclein, and TDP43 - thereby improving synaptic transmission, axonal transport and neuroinflammation. Dysregulation of these pathways has been shown to be the cause of nerve cell degeneration and ultimately death. By attacking these pathways, buntanetap has the ability to reverse neurodegeneration in Alzheimer’s disease.

About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and Twitter.

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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding 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. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Contacts:
Maria Maccecchini, Ph.D.
maccecchini@annovisbio.com

What is the status of Annovis Bio, Inc.'s phase II/III study for Alzheimer's drug candidate buntanetap?

Annovis Bio, Inc. has announced the completion of the phase II/III study for its lead candidate buntanetap in patients with mild to moderate Alzheimer's disease.

Who is leading the efforts at Annovis Bio, Inc. for developing new therapies for neurodegenerative diseases?

Maria Maccecchini, Ph.D., the Founder, President, and CEO of Annovis Bio, Inc., is leading the efforts for developing new therapies for neurodegenerative diseases.

How many patients participated in the phase II/III trial for buntanetap?

A total of 353 patients were initially enrolled in the phase II/III trial for buntanetap, with 327 patients successfully concluding the study.

What is the focus of Annovis Bio, Inc.'s team post the completion of the Alzheimer's study?

The team at Annovis Bio, Inc. is now fully focused on cleaning and analyzing the data from the completed study to deliver results in a timely manner.