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60 Degrees Pharmaceuticals Expands Tafenoquine Clinical Trial for Babesiosis to Brigham and Women’s Hospital
The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical unmet medical need.The clinical site is
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical unmet medical need.The clinical site is led by Brigham and Women’s Hospital researchers Ann Woolley, M.D., and David Leaf, M.D.The double-blind, placebo-controlled trial will examine outcomes for hospitalized patients with severe babesiosis, a tick-borne illness often found as a co-infection of Lyme disease. WASHINGTON, Dec. 11, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (60 Degrees Pharmaceuticals or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has entered into a clinical trial agreement with Brigham and Women’s Hospital (BWH) 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 (NAT) approved by the U.S. Food and Drug Administration (FDA). 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. “We are pleased to be collaborating with Brigham and Women’s Hospital on finding answers to the question of how to bring a safe and effective new treatment option to people hospitalized with severe babesiosis, a potentially life-threatening tick-borne illness,” said Geoffrey Dow, PhD, chief executive officer and president of 60 Degrees Pharmaceuticals. “In the near term, this collaboration promises to substantially enhance our ability to complete enrollment of this important clinical trial during the 2025 tick season. We look forward to a productive collaboration with the Hospital.” A recently published case stu...