60 Degrees Pharmaceuticals (SXTP) has entered into a clinical trial agreement with Brigham and Women’s Hospital in Boston to conduct a double-blind, placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized babesiosis patients. The study, a randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of tafenoquine in treating human babesiosis patients is also underway at Tufts Medical Center in Boston, Yale University, and Rhode Island Hospital, and is sponsored by 60 Degrees Pharmaceuticals. The two main study endpoints will be the time to sustained clinical resolution of symptoms and the time to molecular cure as determined by nucleic acid test approved by the U.S. Food and Drug Administration. At least 24, and as many as 33 patients, will be recruited in the summer of 2025, with an interim analysis anticipated early in 2026. The interim analysis will include both a test of significance, and size re-estimation to allow additional recruitment if required.
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