MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) 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. This advancement follows extensive development and testing of the drug’s new crystalline form.
In June 2024, Annovis filed a composition of matter patent for the new crystal form of buntanetap and a provisional patent for its manufacturing process. The company conducted comprehensive studies, comparing the old semi-crystalline form with the new crystalline form in various solvents and animal models. Additionally, Annovis developed a novel large-scale manufacturing process for the new form. The detailed data from these studies was submitted to the FDA for review.
Buntanetap, previously 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 can cause nerve cell degeneration and death. By targeting these pathways, buntanetap has the potential to reverse neurodegeneration in Alzheimer’s, Parkinson’s, and other neurodegenerative diseases, aiming to restore brain function and improve the quality of life for patients.
The FDA’s approval enables Annovis to conduct a comparative study between the old and new forms of buntanetap. This will involve a small, single-dose bioavailability study in humans as part of the transition process.
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