MALVERN, Pa., Oct. 15, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced today the successful outcome of the End-of-Phase 2 meeting with the U.S.

宾夕法尼亚州马尔文，2024年10月15日（环球通讯社）--通过IBN-Annovis Bio Inc.（纽约证交所：ANVS）（“Annovis”或“公司”），一家开发阿尔茨海默病（AD）和帕金森病（PD）等神经退行性疾病转化疗法的晚期临床药物平台公司，今天宣布了与美国第二阶段会议结束的成功结果。

Food and Drug Administration (FDA) on October 10, 2024. During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap towards the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy.The Phase 3 program will investigate buntanetap in patients with early AD and will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month study designed to demonstrate potential disease-modifying effects.

食品和药物管理局（FDA）于2024年10月10日发布。在会议期间，FDA根据该公司2/3期临床数据显示早期AD患者症状改善，批准进行关键的3期研究。安诺维斯和美国食品和药物管理局现在已经为buntanetap制定了一条提交新药申请（NDA）的发展道路，一条用于短期，另一条用于长期疗效。第三阶段计划将调查早期AD患者的buntanetap，包括两项试验：一项为期6个月的研究旨在确认buntanetap的症状作用，另一项为期18个月的研究旨在证明潜在的疾病缓解作用。

While the Company plans to run both studies, the completion of a well-designed and well-executed 6-month trial may be sufficient to support an NDA filing, potentially within one year of the study’s initiation.Additionally, the FDA raised no concerns about the Company’s data on buntanetap’s safety, including liver enzymes, drug interactions, dose selection, pharmacokinetics, and population pharmacokinetics and confirmed that development can proceed using the new crystal form of buntanetap.“We are now ready to move into the highly anticipated Phase 3 stage,” said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio.

虽然该公司计划进行这两项研究，但完成精心设计且执行良好的6个月试验可能足以支持NDA申请，可能在研究开始后的一年内。此外，FDA对该公司关于buntanetap安全性的数据（包括肝酶，药物相互作用，剂量选择，药代动力学和群体药代动力学）没有提出任何担忧，并证实可以使用buntanetap的新晶体形式进行开发。Annovis Bio的创始人、总裁兼首席执行官玛丽亚·麦克切奇尼（MariaMaccecchini）博士说：“我们现在准备进入备受期待的第三阶段。”。

“Our priority is to bring the treatment to patients as early as possible, and we are committed to ensuring.

“我们的首要任务是尽早为患者提供治疗，我们致力于确保。