Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap
Annovis Bio (NYSE: ANVS) has received FDA approval to transition to a new crystal form of buntanetap in future clinical trials. This follows the company's June 2024 announcement of filing a composition of matter patent for the new crystal form and a provisional patent for its manufacturing process. Annovis conducted comprehensive bridge studies comparing the old semi-crystalline form with the new crystalline form in various solvents and animals. The company also developed a large-scale manufacturing process for the new form. The FDA's approval allows Annovis to conduct a comparative bioavailability study in humans as part of the transition process.
- FDA approval to use new crystal form of buntanetap in future clinical trials
- Filing of composition of matter patent for new crystal form
- Development of large-scale manufacturing process for new form
- Potential for improved drug efficacy or manufacturing efficiency with new crystal form
- Additional clinical studies required for transition to new crystal form
- Potential delays in overall drug development timeline due to transition process
FDA approval for a new crystal form of buntanetap marks a significant milestone for Annovis Bio, given the potential implications for treating neurodegenerative diseases such as Alzheimer’s and Parkinson’s. The approval suggests that the data provided by Annovis on the new crystalline form and its manufacturing process met the FDA's rigorous standards. This is an indication of the company's
However, it's essential to note that the positive FDA response mainly pertains to future clinical trials. The actual impact on long-term treatment outcomes and commercial viability remains to be seen. Investors should monitor the results from the upcoming comparative bioavailability studies as it could significantly influence the drug's market potential.
The FDA's approval for Annovis Bio to transition to a new crystal form of buntanetap is noteworthy from a financial perspective. The potential improvements in manufacturability and bioavailability can lead to more efficient production processes, potentially reducing
However, while the approval is a step forward, many uncertainties remain. The comparative bioavailability study will be important in determining whether the new crystal form truly offers superior benefits. Additionally, the impact on the company's financials will only become clear once the drug progresses through the clinical trial phases and moves closer to commercialization. Investors should remain cautious and look for updates on clinical trial results and any potential partnership or licensing deals that may arise from this development.
For retail investors, this news underscores Annovis Bio's proactive approach in enhancing its drug formulation and aligning with regulatory guidelines. The approval to use a new crystal form of buntanetap could provide a competitive edge by potentially offering a more effective and marketable product. This move can also attract attention from bigger pharmaceutical companies interested in partnerships or acquisitions, given the high stakes in the neurodegenerative disease market.
Nonetheless, the ultimate impact on Annovis Bio’s market position will depend on the outcomes of the bioavailability studies and subsequent clinical trials. Positive results could lead to a significant revaluation of the company's stock as it would validate the efficacy of the new formulation. Investors should keep an eye on the progress of these trials and any strategic moves by the company to leverage this approval for broader market reach.
MALVERN, Pa., July 16, 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 that it has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials.
In June 2024, Annovis announced the filing of a composition of matter patent for the new crystal form of buntanetap and a provisional patent for the manufacturing process of this new form. The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap. Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review.
The FDA has now approved the continuation of buntanetap's development using the new crystal form. This positive response allows Annovis to conduct a comparative study between the old and new forms of buntanetap in a small, single-dose, bioavailability study in humans as part of the transition process.
About Buntanetap
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.
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.
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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.
Contacts
Annovis Bio, Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
IR@annovisbio.com
Investor Website
FAQ
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