MALVERN, Pa., June 27, 2024 – Annovis Bio Inc. (NYSE: ANVS), a company at the forefront of developing innovative treatments for neurodegenerative diseases such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), has officially filed a provisional patent for a novel manufacturing process for new solid forms of buntanetap. This patent covers methods for manufacturing a newly developed crystalline form of buntanetap (CAS# 3032752-92-1), which has shown remarkable stability and effectiveness. The patent also includes the full synthesis process from initial materials to a final product that is over 99.9% pure and suitable for large-scale manufacturing.
The new manufacturing process offers numerous benefits, such as excellent yields and the exclusion of potentially harmful genotoxic reagents, resulting in a purer product. Annovis has submitted the Chemistry, Manufacturing, and Controls (CMC) protocol to the FDA, with a discussion scheduled for July. The company aims to continue the development of this drug and eventually file a New Drug Application (NDA) using the new crystalline form.
Michael Christie, Ph.D., Vice President of Process Chemistry at Annovis, emphasized the importance of this development: "Securing our manufacturing rights for new forms of buntanetap is crucial. It allows us to maintain control over the production process, protect our intellectual property, and remain committed to delivering innovative treatments for patients with neurodegenerative disorders."
Buntanetap, previously known as Posiphen or ANVS401, targets neurodegeneration by inhibiting the formation of several neurotoxic proteins, such as amyloid beta, tau, alpha-synuclein, and TDP43. This mechanism enhances synaptic transmission, and axonal transport, and reduces neuroinflammation. Dysregulation of these pathways leads to nerve cell degeneration and death. By addressing these pathways, buntanetap has the potential to reverse neurodegeneration in conditions like Alzheimer’s and Parkinson’s, aiming to restore brain function and improve patients' quality of life.
Annovis Bio Inc., headquartered in Malvern, Pennsylvania, is committed to combating neurodegeneration in diseases such as AD and PD. The company's innovative approach targets multiple neurotoxic proteins to restore brain function and enhance the quality of life for patients.
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