Annovis Bio Gets FDA Approval for New Buntanetap Crystal Form

MALVERN, Pa., July 16, 2024 -- Annovis Bio Inc. (NYSE: ANVS), a company dedicated to the development of groundbreaking therapies for neurodegenerative diseases such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), announced that it has received FDA approval to proceed with a new solid form of its drug, buntanetap, in forthcoming clinical trials. In June 2024, Annovis had disclosed the filing of a composition of matter patent for a new crystal form of buntanetap and a provisional patent for its manufacturing process.

Annovis conducted extensive bridge studies involving various solvents and animal models to compare the old semi-crystalline version with the new crystalline form of buntanetap. The company also developed a novel, large-scale manufacturing process for the new form. All this comprehensive data was furnished to the FDA for evaluation, and the agency has now given the green light for the continued development using the new crystal form. This approval enables Annovis to carry out a comparative study between the old and new forms of buntanetap in a small-scale, single-dose bioavailability study in human subjects as part of its transition.

Buntanetap, previously known as Posiphen or ANVS401, is an innovative drug targeting neurodegeneration. It works by inhibiting the formation of various neurotoxic proteins such as amyloid beta, tau, alpha-synuclein, and TDP43. This leads to improved synaptic transmission and axonal transport while also reducing neuroinflammation. Dysregulation of these pathways is known to cause nerve cell degeneration and death. By addressing these pathways, buntanetap aims to reverse neurodegeneration in Alzheimer’s, Parkinson’s, and other neurodegenerative diseases, potentially restoring brain function and enhancing patients' quality of life.

Annovis Bio Inc., headquartered in Malvern, Pennsylvania, is committed to tackling neurodegenerative diseases like AD and PD. The company's pioneering approach focuses on multiple neurotoxic proteins, with the goal of rejuvenating brain function and improving life quality for those affected. 

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