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8-K: Current report

SEC announcement ·  May 2 16:35
Summary by Moomoo AI
On May 2, 2024, 60 Degrees Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided feedback on the protocol for a planned clinical trial to study the use of tafenoquine in treating babesiosis, a tick-borne illness. The FDA's comments included questions and recommendations, but no material changes to the trial design or protocol are required. The company is moving forward with preparations to begin patient enrollment later in the year. This follows a Type C regulatory meeting with the FDA and the submission of the full protocol under an existing Investigational New Drug application. Tafenoquine is currently approved for malaria prophylaxis under the name ARAKODA®. The upcoming study will be a randomized double-blind placebo-controlled...Show More
On May 2, 2024, 60 Degrees Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided feedback on the protocol for a planned clinical trial to study the use of tafenoquine in treating babesiosis, a tick-borne illness. The FDA's comments included questions and recommendations, but no material changes to the trial design or protocol are required. The company is moving forward with preparations to begin patient enrollment later in the year. This follows a Type C regulatory meeting with the FDA and the submission of the full protocol under an existing Investigational New Drug application. Tafenoquine is currently approved for malaria prophylaxis under the name ARAKODA®. The upcoming study will be a randomized double-blind placebo-controlled trial, set to enroll at least 24 patients across three hospitals in the northeastern United States. The main endpoints will be the time to sustained clinical resolution of symptoms and molecular cure as determined by an FDA-approved nucleic acid test. The drug's efficacy and safety for malaria prevention have been established, and case studies suggest its use for babesiosis in the U.S. The company, which specializes in developing medicines for infectious diseases, received FDA approval for ARAKODA® in 2018 and has collaborations with research organizations in the U.S., Australia, and Singapore.

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