MALVERN, Pa., July 16, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), announced today that it has received approval from the U.S.

宾夕法尼亚州马尔文，2024年7月16日（环球通讯社）--通过IBN-Annovis Bio Inc.（纽约证券交易所：ANVS）（“Annovis”或“公司”），一家晚期临床药物平台公司，开创了阿尔茨海默病（AD）和帕金森病（PD）等神经退行性疾病的转化疗法，今天宣布已获得美国批准。

Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials.In June 2024, Annovis announced the filing of a composition of matter patent for the new crystal form of buntanetap and a provisional patent for the manufacturing process of this new form. The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap.

美国食品和药物管理局（FDA）将在未来的临床试验中过渡到新的固体形式的buntanetap。2024年6月，安诺维斯宣布为新晶型的buntanetap申请物质组成专利，并为这种新晶型的制造工艺申请临时专利。该公司在各种溶剂和动物中进行了全面的桥接研究，比较了旧的半晶型和新晶型的buntanetap。

Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review.The FDA has now approved the continuation of buntanetap's development using the new crystal form. This positive response allows Annovis to conduct a comparative study between the old and new forms of buntanetap in a small, single-dose, bioavailability study in humans as part of the transition process.About BuntanetapBuntanetap (formerly known as Posiphen or ANVS401) targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein, and TDP43.

此外，Annovis为新表格开发了一种创新的大规模制造工艺。该综合数据已提交给FDA审查。美国食品和药物管理局（FDA）现已批准继续使用这种新的晶体形式开发布坦塔普。这种积极的反应使Annovis能够在人类小剂量单剂量生物利用度研究中对新旧形式的布坦塔普进行比较研究，作为过渡过程的一部分。关于BuntanetapBuntanetap（以前称为Posiphen或ANVS401）通过抑制多种神经毒性蛋白（包括淀粉样蛋白β，tau，α-突触核蛋白和TDP43）的形成来靶向神经变性。

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, Pa.

这改善了突触传递，轴突运输，并减少了神经炎症。这些途径的失调已被证明会导致神经细胞变性并最终导致神经细胞死亡。通过靶向这些途径，buntanetap有可能逆转宾夕法尼亚州阿尔茨海默氏病的神经变性。