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8-K: Current report

8-K: Current report

8-K:重大事件
美股sec公告 ·  07/10 03:41
牛牛AI助理已提取核心訊息
On July 9, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a clinical trial at Tufts Medical Center for the treatment of Babesiosis using tafenoquine. This trial is significant as it is the first of its kind and aims to confirm the 80% cure rate observed in a previous Yale School of Public Health study. The earlier study, published in Clinical Infectious Diseases, showed promising results in a small group of immunosuppressed patients. While tafenoquine is currently approved for malaria prophylaxis under the name ARAKODA, it is not yet approved for the treatment or prevention of Babesiosis, a tick-borne illness that can be life-threatening, especially in the elderly and immunocompromised. The company's press release, which is...Show More
On July 9, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a clinical trial at Tufts Medical Center for the treatment of Babesiosis using tafenoquine. This trial is significant as it is the first of its kind and aims to confirm the 80% cure rate observed in a previous Yale School of Public Health study. The earlier study, published in Clinical Infectious Diseases, showed promising results in a small group of immunosuppressed patients. While tafenoquine is currently approved for malaria prophylaxis under the name ARAKODA, it is not yet approved for the treatment or prevention of Babesiosis, a tick-borne illness that can be life-threatening, especially in the elderly and immunocompromised. The company's press release, which is part of the SEC filing, outlines the ongoing efforts to repurpose tafenoquine for Babesiosis treatment, with plans to file a New Drug Application with the FDA in the second quarter of 2026. The company is also conducting additional studies to address the unmet medical needs of different Babesiosis patient populations. 60 Degrees Pharmaceuticals, which specializes in infectious disease treatments, has already achieved FDA approval for ARAKODA for malaria prevention and is actively engaged in research collaborations.
2024年7月9日,60 Degrees Pharmaceuticals公司在塔夫茨醫學中心宣佈,第一位患者已經在臨床試驗中使用替魯奎治療犬瘧熱。該試驗具有重要意義,因爲它是首次試驗,旨在確認之前在耶魯公共衛生學院一項研究中觀察到的80%的治癒率。早前的研究發表在《臨床傳染病》雜誌上,展示了一小組免疫抑制患者的有希望的結果。雖然替魯奎目前被批准用於瘧疾預防,名爲ARAKODA,但尚未被批准用於犬瘧熱的治療或預防,這是一種可以威脅生命的由蜱傳播的疾病,尤其是老年人和免疫受損者。該公司的新聞稿是證券交易委員會備案的一部分,概述了繼續努力將替魯奎重新用於犬瘧熱的治療,並計劃在2026年第二季度向FDA提交新藥申請。該公司還正在開展其他研究,以解決不同犬瘧熱患者人群的不同醫療需求。60 Degrees Pharmaceuticals專門從事傳染病治療,並已經獲得了ARAKODA用於瘧疾預防的FDA批准,並積極與研究合作。
2024年7月9日,60 Degrees Pharmaceuticals公司在塔夫茨醫學中心宣佈,第一位患者已經在臨床試驗中使用替魯奎治療犬瘧熱。該試驗具有重要意義,因爲它是首次試驗,旨在確認之前在耶魯公共衛生學院一項研究中觀察到的80%的治癒率。早前的研究發表在《臨床傳染病》雜誌上,展示了一小組免疫抑制患者的有希望的結果。雖然替魯奎目前被批准用於瘧疾預防,名爲ARAKODA,但尚未被批准用於犬瘧熱的治療或預防,這是一種可以威脅生命的由蜱傳播的疾病,尤其是老年人和免疫受損者。該公司的新聞稿是證券交易委員會備案的一部分,概述了繼續努力將替魯奎重新用於犬瘧熱的治療,並計劃在2026年第二季度向FDA提交新藥申請。該公司還正在開展其他研究,以解決不同犬瘧熱患者人群的不同醫療需求。60 Degrees Pharmaceuticals專門從事傳染病治療,並已經獲得了ARAKODA用於瘧疾預防的FDA批准,並積極與研究合作。

譯文內容由第三人軟體翻譯。


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