60 Degrees Pharmaceuticals has signed clinical trial agreements with three clinical trial sites to carry out the study of tafenoquine to treat babesiosis.
Yale University, Tufts Medical Center and Rhode Island Hospital have started enrolling trial subjects in the study of tafenoquine.
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This randomised, placebo-controlled double-blind trial is designed to assess the efficacy and safety of tafenoquine in treating hospitalised patients with babesiosis, along with standard-of-care treatments.
Its key endpoints will focus on the time to sustained clinical resolution of symptoms and the time to molecular cure.
The trial is expected to recruit between 24 to 33 patients before an interim analysis is conducted, with sufficient enrolment capacity planned to ensure all subjects are recruited before the end of the 2025 tick season.
The interim assessment will include a test of significance and a size re-estimation to allow further subject recruitment if required.
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By GlobalDataTafenoquine is already being utilised off-label for babesiosis treatment in the US, as indicated by several case reports.
Babesiosis, transmitted by the black-legged tick, is an infectious disease that can be life-threatening, especially in the elderly and immunosuppressed individuals.
Although tafenoquine has been approved for malaria prophylaxis in the US, its potential for the treatment or prevention of babesiosis is not yet proven and lacks approval for such indications.
60 Degrees Pharmaceuticals CEO Dr Geoff Dow said: “The Tafenoquine for Babesiosis clinical trial currently enrolling patients is anticipated to shed new light on how best to address the babesiosis treatment needs of this group.
“The team at 60 Degrees Pharmaceuticals is pleased to partner with Tufts Medical Center, Yale University, and Rhode Island Hospital – three of the world’s leading medical centres – in this effort.”
