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 our drug and filing the NDA with the new crystal form.
“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
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.
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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
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