Annovis Bio Files Provisional Patent for New Manufacturing Process of Crystalline Form of Buntanetap
Annovis Bio announced the filing of a provisional patent for a new manufacturing process of a crystalline form of buntanetap, a drug for neurodegenerative disorders like Alzheimer's and Parkinson's diseases. This new process provides significant benefits, including high product purity, excellent yields, and the avoidance of genotoxic reagents. The company aims to submit the Chemistry, Manufacturing, and Controls (CMC) protocol to the FDA in July, with plans to continue the drug's development and file a New Drug Application (NDA).
- Filing of a provisional patent for the manufacturing process of buntanetap.
- The new process yields a purer product (>99.9% purity) suitable for large-scale production.
- Process avoids the use of genotoxic reagents.
- Submission of CMC protocol to the FDA pending for July, indicating progress toward NDA filing.
- None.
Insights
The filing of a provisional patent for a new manufacturing process, particularly one involving a new crystalline form, is a significant step for any pharmaceutical company. This development from Annovis Bio Inc. indicates not just innovation but also optimization in production, which is important for scalability and consistent quality. The mention of higher yields and avoidance of genotoxic reagents points to a safer and more efficient production process, potentially lowering costs and increasing output. This can translate into better margins and a more robust supply chain, which are critical factors in the pharmaceutical industry where manufacturing complexities often lead to bottlenecks. Furthermore, the new crystalline form being >99.9% pure suggests a high level of efficacy and stability, which can enhance patient outcomes and boost the drug's market acceptance.
For investors, Annovis Bio's move to file a provisional patent for their new crystalline form of buntanetap is noteworthy. Patents play a vital role in protecting intellectual property, giving companies a competitive edge by preventing competitors from using the same technology. This new manufacturing process could lead to cost savings by improving yields and eliminating expensive, potentially harmful reagents. Moreover, submitting the CMC protocol to the FDA indicates regulatory progress, a key milestone that can significantly affect the company's valuation. Should the FDA discussions in July go well, it could hasten the drug’s path to market, driving revenue growth. Investors should keep an eye on the regulatory updates, as they will provide more concrete timelines and risk assessments moving forward.
The introduction of a new crystalline form of buntanetap with exceptional stability and efficacy is a promising advancement for treating neurodegenerative disorders like Alzheimer’s and Parkinson’s Diseases. Stability and purity are critical for therapeutic efficacy, patient safety and regulatory approval. The fact that this new form avoids genotoxic reagents adds an extra layer of patient safety, potentially leading to wider acceptance among prescribers and patients. Furthermore, this development might offer Annovis Bio a competitive edge in a crowded market where differentiation often hinges on such innovations. The focus on advancing their pipeline underscores Annovis’ commitment to bringing new, effective treatments to market, which could attract attention from both the medical community and investors looking for breakthrough therapies.
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 (>
“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.
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.
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.
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
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