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8-K: Current report

8-K: Current report

8-K:重大事件
美股sec公告 ·  07/09 15:41
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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, Inc.宣佈在塔夫茨醫療中心招募第一位病人蔘加一項臨床試驗,以使用他莫奎因治療巴貝氏菌病。這項試驗非常重要,因爲它是首個旨在確認之前耶魯公共衛生學院研究中觀察到的80%治癒率的試驗。先前的研究發表在《臨床傳染病學》中,對小規模免疫抑制患者群體顯示了有希望的結果。儘管他莫奎因目前作爲ARAKODA用於瘧疾預防,但尚未獲得治療或預防巴貝氏菌病的批准,這種蜱傳疾病可能會危及生命,尤其是對老年人和免疫系統薄弱者。該公司的新聞稿是SEC文件的一部分,概述了重複使用他莫奎因進行巴貝氏菌病治療的不斷努力,計劃在2026年第二季度向FDA提交新藥申請。該公司還進行了其他研究,以解決不同的巴貝氏菌病患者群體的未滿足醫療需求。60 Degrees Pharmaceuticals公司專門從事傳染病治療,並已獲得ARAKODA用於瘧疾預防的FDA批准,並積極參與研究合作。
2024年7月9日,60 Degrees Pharmaceuticals, Inc.宣佈在塔夫茨醫療中心招募第一位病人蔘加一項臨床試驗,以使用他莫奎因治療巴貝氏菌病。這項試驗非常重要,因爲它是首個旨在確認之前耶魯公共衛生學院研究中觀察到的80%治癒率的試驗。先前的研究發表在《臨床傳染病學》中,對小規模免疫抑制患者群體顯示了有希望的結果。儘管他莫奎因目前作爲ARAKODA用於瘧疾預防,但尚未獲得治療或預防巴貝氏菌病的批准,這種蜱傳疾病可能會危及生命,尤其是對老年人和免疫系統薄弱者。該公司的新聞稿是SEC文件的一部分,概述了重複使用他莫奎因進行巴貝氏菌病治療的不斷努力,計劃在2026年第二季度向FDA提交新藥申請。該公司還進行了其他研究,以解決不同的巴貝氏菌病患者群體的未滿足醫療需求。60 Degrees Pharmaceuticals公司專門從事傳染病治療,並已獲得ARAKODA用於瘧疾預防的FDA批准,並積極參與研究合作。
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