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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
Moomoo AI 已提取核心訊息
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公司宣佈，已在圖夫斯醫療中心招募第一位病人，開展一項重大的臨床試驗，評估替非諾酮治療棕色巴貝氏菌病的療效和安全性。該項試驗是全球首個此類試驗，旨在招募24至33名患者。該研究是一項隨機、雙盲、安慰劑對照試驗，終點評估焦點爲持續症狀臨床緩解時間和分子治癒時間，其中後者是由美國FDA認可的核酸測試進行確定的。替非諾酮目前在瘧疾預防方面獲得批准，其商品名爲ARAKODA®，但其還未獲得治療或預防棕色巴貝氏菌病的批准。然而，它已被美國FDA指定爲孤兒藥物以治療該病症。該試驗將在2024年蜱蟲季節期間進行，可能會擴大範圍幷包括其他大學醫院。該公司專門開發感染性疾病的藥物，此前已獲得ARAKODA®用於瘧疾預防的FDA批准，並正在與美國、澳洲和新加坡的研究機構合作。
2024年6月27日，60 Degrees Pharmaceuticals公司宣佈，已在圖夫斯醫療中心招募第一位病人，開展一項重大的臨床試驗，評估替非諾酮治療棕色巴貝氏菌病的療效和安全性。該項試驗是全球首個此類試驗，旨在招募24至33名患者。該研究是一項隨機、雙盲、安慰劑對照試驗，終點評估焦點爲持續症狀臨床緩解時間和分子治癒時間，其中後者是由美國FDA認可的核酸測試進行確定的。替非諾酮目前在瘧疾預防方面獲得批准，其商品名爲ARAKODA®，但其還未獲得治療或預防棕色巴貝氏菌病的批准。然而，它已被美國FDA指定爲孤兒藥物以治療該病症。該試驗將在2024年蜱蟲季節期間進行，可能會擴大範圍幷包括其他大學醫院。該公司專門開發感染性疾病的藥物，此前已獲得ARAKODA®用於瘧疾預防的FDA批准，並正在與美國、澳洲和新加坡的研究機構合作。
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