60 Degrees Pharmaceuticals has embarked on a significant clinical trial to explore the treatment of babesiosis, a potentially life-threatening disease transmitted by the black-legged tick. The company has entered into agreements with three prestigious institutions: Yale University, Tufts Medical Center, and Rhode Island Hospital, to conduct this study.
The trial is a randomised, placebo-controlled double-blind study aimed at evaluating the efficacy and safety of tafenoquine in treating hospitalised patients with babesiosis, alongside standard-of-care treatments. Key endpoints of the study include the time to sustained clinical resolution of symptoms and the time to molecular cure.
Enrollment for the trial has commenced, with plans to recruit between 24 to 33 patients before an interim analysis is performed. This analysis will include a test of significance and a size re-estimation to potentially allow for further subject recruitment if necessary. The trial is designed to ensure all subjects are recruited before the end of the 2025 tick season.
Tafenoquine, while already used off-label for babesiosis treatment in the US, lacks approval for this specific indication. The drug has been approved for malaria prophylaxis, but its effectiveness in treating or preventing babesiosis remains unproven.
Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, expressed enthusiasm about the trial, stating, "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." He also highlighted the privilege of collaborating with leading medical centers in this endeavor.
This clinical trial represents a crucial step forward in understanding and potentially improving treatment options for babesiosis, especially for vulnerable populations such as the elderly and immunosuppressed individuals.