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Annovis Bio Files Provisional Patent for New Manufacturing Process of Crystalline Form of Buntanetap

Key Takeaway: Annovis Bio Inc. has filed a provisional patent for a new manufacturing process of a crystalline form of its drug, buntanetap, which targets neurodegenerative disorders such as Alzheimer's and Parkinson's Disease. This patent covers all aspects of production, ensuring control and protection of intellectual property. The new process is expected to yield a purer product and avoid harmful reagents. Annovis plans to submit a New Drug Application (NDA) based on this new crystal form, demonstrating its commitment to advancing treatment options for patients with neurodegenerative conditions.

Market Sentiment Analysis

POSITIVE FACTORS

  • Filing of a provisional patent for a new crystalline form of buntanetap.
  • The new manufacturing process demonstrates exceptional stability and efficacy.
  • Significant benefits include excellent yields and avoidance of potentially genotoxic reagents.
  • The potential for buntanetap to reverse neurodegeneration in diseases like Alzheimer's and Parkinson's.

Full Press Release Details

MALVERN, Pa., June 27, 2024 (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 disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), announced today the filing of a provisional patent covering the manufacturing process of new solid forms of buntanetap.
This patent encompasses the methods for manufacturing the new crystalline form of buntanetap (CAS# 3032752-92-1), which has demonstrated exceptional stability and efficacy. The patent also covers the entire synthesis process, from basic starting materials to finished (>99.9% pure) GMP product, suitable for manufacturing scale at ton quantities. The new process offers significant benefits, including excellent yields, the avoidance of potentially genotoxic reagents, and a purer product. The CMC protocol was submitted to the FDA and will be discussed in July, with the goal of continuing development of our drug and filing the NDA with the new crystal form.
“As we continue to advance our pipeline, securing our manufacturing rights for new forms of buntanetap is vital. This ensures we maintain control over the production process, protect our intellectual property, and continue our mission to deliver novel therapeutics for patients suffering from neurodegenerative disorders,” said Michael Christie, Ph.D., Vice President of Process Chemistry at Annovis.
Buntanetap (formerly known as Posiphen or ANVS401) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43. This improves synaptic transmission, axonal transport, and reduces neuroinflammation. Dysregulation of these pathways has been shown to cause nerve cell degeneration and ultimately nerve cell death. By targeting these pathways, buntanetap has the potential to reverse neurodegeneration in Alzheimer’s, Parkinson’s, and other neurodegenerative diseases, thereby aiming to restore brain function and improve the quality of life for patients.
About Annovis Bio, Inc.
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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Tags

neurodegenerative disorders

Frequently Asked Questions

What is Annovis Bio focused on?

Annovis Bio develops therapies for neurodegenerative disorders like Alzheimer's and Parkinson's.

What does the new patent for buntanetap cover?

The patent covers the manufacturing process for new crystalline forms of buntanetap, ensuring stability and purity.

How does buntanetap work?

Buntanetap targets neurodegeneration by inhibiting neurotoxic proteins, improving brain function.

What are the benefits of the new manufacturing process?

The new process offers excellent yields, avoids genotoxic reagents, and ensures a purer product.

When will the CMC protocol be discussed with the FDA?

The CMC protocol is set for discussion with the FDA in July 2024.

Last updated: Jun 27, 2024