Annovis Bio Inc. announced 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 (>99.9% pure) GMP product, suitable for manufacturing scale at ton quantities.

The new process offers significant benefits, including excellent yields, the avoidance of potentially genotoxic reagents, and a purer product. The CMC protocol was submitted to the FDA and will be discussed in July, with the goal of continuing development of drug and filing the NDA with the new crystal form. 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.