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8-K: Current report

8-K: Current report

8-K：重大事件
美股sec公告 ·  06/27 17:10
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On June 27, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine for the treatment of Babesiosis. This trial is the first of its kind globally and aims to enroll between 24 to 33 patients. The study is a randomized, double-blind, placebo-controlled trial with endpoints focusing on the time to sustained clinical resolution of symptoms and molecular cure as determined by an FDA-approved nucleic acid test. Tafenoquine, currently approved for malaria prophylaxis under the name ARAKODA®, has not yet been approved for the treatment or prevention of Babesiosis. However, it has been designated as an orphan drug by the U.S. Food...Show More
On June 27, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine for the treatment of Babesiosis. This trial is the first of its kind globally and aims to enroll between 24 to 33 patients. The study is a randomized, double-blind, placebo-controlled trial with endpoints focusing on the time to sustained clinical resolution of symptoms and molecular cure as determined by an FDA-approved nucleic acid test. Tafenoquine, currently approved for malaria prophylaxis under the name ARAKODA®, has not yet been approved for the treatment or prevention of Babesiosis. However, it has been designated as an orphan drug by the U.S. Food and Drug Administration for this indication. The trial will take place during the 2024 tick season and may expand to include additional university hospitals. The company, which specializes in developing medicines for infectious diseases, has previously achieved FDA approval for ARAKODA® for malaria prevention and is collaborating with research organizations in the U.S., Australia, and Singapore.
2024年6月27日，60 Degrees Pharmaceuticals公司宣布在塔夫茨医疗中心招募了第一个病人，进行一项具有开创意义的临床试验，旨在评估噬血原虫病治疗药物Tafenoquine的疗效和安全性。该试验是全球首个试验，计划招募24至33名患者，采用随机、双盲、安慰剂对照设计，终点评估时间为持续临床症状缓解和分子治愈，由FDA批准的核酸检测来确定。目前，Tafenoquine已在防治疟疾时以ARAKODA®的名字获得批准，但尚未获得治疗或预防噬血原虫病的批准。然而，它已被美国食品和药物管理局指定为孤儿药物。该试验将在2024年的蜱媒季节进行，并可能扩展到包括其他大学医院。这家专门开发传染病药物的公司此前已获得了ARAKODA®针对疟疾预防的FDA批准，并正在与美国、澳洲和新加坡的研究机构合作。
2024年6月27日，60 Degrees Pharmaceuticals公司宣布在塔夫茨医疗中心招募了第一个病人，进行一项具有开创意义的临床试验，旨在评估噬血原虫病治疗药物Tafenoquine的疗效和安全性。该试验是全球首个试验，计划招募24至33名患者，采用随机、双盲、安慰剂对照设计，终点评估时间为持续临床症状缓解和分子治愈，由FDA批准的核酸检测来确定。目前，Tafenoquine已在防治疟疾时以ARAKODA®的名字获得批准，但尚未获得治疗或预防噬血原虫病的批准。然而，它已被美国食品和药物管理局指定为孤儿药物。该试验将在2024年的蜱媒季节进行，并可能扩展到包括其他大学医院。这家专门开发传染病药物的公司此前已获得了ARAKODA®针对疟疾预防的FDA批准，并正在与美国、澳洲和新加坡的研究机构合作。
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