TARRYTOWN, New York, April 11, 2024 (GLOBE NEWSWIRE) -- via IBN – PaxMedica, Inc. (NASDAQ:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, today announced the completed execution of its three pivotal registration/validation batches of PAX-101, an IV formulation of suramin.

纽约塔里敦，2024年4月11日（环球通讯社）--通过专注于推进神经系统疾病治疗的生物制药公司IBN-PaxMedica，Inc.（纳斯达克：PXMD），今天宣布完成其三个关键注册/验证批次的PAX-101（苏拉明的IV制剂）的执行。

This achievement is an important milestone to enabling a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which is currently planned for Q4 2024, and for the potential commercial availability in the U.S. of the first and only form of suramin for the treatment of Stage 1 Human African Trypanosomiasis (HAT), caused by Trypanosoma brucei rhodesiense, a fatal, neglected tropical disease, if approved by the FDA.

这一成就是一个重要的里程碑，有助于向美国食品和药物管理局（FDA）提交新药申请（NDA），该申请目前计划于2024年第四季度提交，并且如果FDA批准，将在美国商业上提供第一种也是唯一一种苏拉明，用于治疗由布氏锥虫罗得西亚锥虫（一种致命的被忽视的热带疾病）引起的1期人类非洲锥虫病（HAT）。

Reaching this milestone is critical to PaxMedica's journey towards potential FDA approval for PAX-101, currently the accepted standard of treatment outside the United States for the deadliest cause of HAT, according to the CDC. A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV).

根据疾病预防控制中心的说法，达到这一里程碑对于PaxMedica走向FDA批准PAX-101的道路至关重要，PAX-101目前是美国以外最致命的HAT治疗标准。NDA的成功审查和批准可能进一步使公司有资格获得热带病优先审查凭证（PRV）。

PaxMedica plans to fund a sustainable global supply chain for PAX-101, and further advance research and clinical trials to address Autism Spectrum Disorder. This underscores the company’s commitment to tackling some of the most challenging neurological conditions. “This is a very significant milestone for PaxMedica as it endeavors to move PAX-101 towards an NDA submission,” said Howard Weisman, chairman and CEO of PaxMedica.

PaxMedica计划为PAX-101的可持续全球供应链提供资金，并进一步推进研究和临床试验，以解决自闭症谱系障碍。这突显了该公司致力于解决一些最具挑战性的神经系统疾病。PaxMedica董事长兼首席执行官霍华德·韦斯曼（HowardWeisman）表示：“这对PaxMedica来说是一个非常重要的里程碑，因为它正在努力将PAX-101推向NDA提交。”。

“The long-term vision for PaxMedica is to further clinical investigation of PAX-101 as a treatment for individuals who struggle with Autism Spectrum Disorder. With this important manufacturing milestone completed, we have removed a major imp.

“PaxMedica的长期愿景是进一步对PAX-101进行临床研究，以治疗自闭症谱系障碍患者。随着这一重要的制造里程碑的完成，我们删除了一个主要的imp。