Following a Type C meeting with FDA on January 17, 2024, 60 Degrees Pharma (60P) now plans to conduct a pivotal clinical study in support of a future indication for tafenoquine for treatment of hospitalized babesiosis patientsPatient enrollment to begin in summer of 2024 WASHINGTON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc.

在2024年1月17日与FDA举行C型会议后，60度制药（60P）现在计划进行一项关键的临床研究，以支持他非诺喹治疗住院巴贝斯虫病患者的未来适应症患者登记将于2024年夏季开始华盛顿，2024年1月22日（环球新闻网）——60度制药公司。

(NASDAQ: SXTP; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that, following a Type C meeting held on January 17, 2024 with the US Food and Drug Administration (FDA), the Company will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S.

专注于开发传染病新药的制药公司（NASDAQ:SXTP；SXTPW）（“60P”或“公司”）今天宣布，在2024年1月17日与美国食品和药物管理局（FDA）举行的C型会议之后，该公司将推进塔非诺喹在美国住院的斯瓦贝斯病患者中的关键临床研究。

In advance of the meeting, 60P provided to the FDA an information package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients. It also included a detailed outline of the proposed study protocol. The FDA indicated in remarks during the meeting that the proposed study could be sufficient for regulatory approval, provided the Company uses a clinical endpoint rather than a surrogate marker.

在会议之前，60P向FDA提供了一个信息包，其中包括对住院巴贝斯虫病患者的新疗法未满足的医疗需求的介绍。它还包括拟议研究方案的详细概述。FDA在会议期间的评论中表示，如果该公司使用临床终点而不是替代标记，则拟议的研究可能足以获得监管部门的批准。

60P is now revising the study protocol in light of that feedback, with the goal of initiating patient enrollment in the summer of 2024. “Our recent Type C meeting with the FDA led to mutual alignment with respect to the design of a development plan to evaluate the ARAKODA® regimen of tafenoquine for treating people who are hospitalized with babesiosis,” said Geoff Dow, Chief Executive Officer of 60 Degrees Pharmaceuticals.

60P目前正在根据这些反馈修改研究方案，目标是在2024年夏天开始患者登记。60度制药首席执行官杰夫·道（GeoffDow）表示：“我们最近与美国食品和药物管理局（FDA）举行的C型会议导致双方在开发计划的设计方面达成一致，该计划旨在评估用于治疗巴贝斯虫病住院患者的他非诺喹ARAKODA®方案。”。

“We are excited to advance this important study, as tick-borne illnesses such as babesiosis are emerging rapidly in the U.S. and can be life-threatening. Our aim is to bring a new treatment.

“我们很高兴推进这项重要的研究，因为蜱传疾病如巴贝斯虫病正在美国迅速出现，并可能危及生命。我们的目标是带来一种新的治疗方法。