60 Degrees Pharmaceuticals Completes Clinical Trial Agreements for Tafenoquine Babesiosis Study

60 Degrees Pharmaceuticals, Inc., a company specializing in the development of new treatments for infectious diseases, has initiated a clinical trial for Tafenoquine aimed at treating babesiosis. Collaborating with Tufts Medical Center, Yale University, and Rhode Island Hospital, this trial represents the world’s first randomized, double-blind, placebo-controlled study assessing the efficacy and safety of tafenoquine in patients with babesiosis. Patient enrollment has started, with interim results expected by September 2025.

Babesiosis, primarily transmitted through tick bites, is a rising health concern in the Northeast United States. It is a disease caused by the Babesia parasite and can be life-threatening, especially for the elderly and immunosuppressed individuals. The increasing incidence of this tick-borne illness has heightened the urgency for effective treatment options.

Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, highlighted the critical need for accurate diagnosis and effective treatment of babesiosis to prevent severe outcomes. Noting the limited treatment options for patients with relapsing babesiosis, Dr. Dow emphasized the potential impact of the ongoing clinical trial on addressing the therapeutic needs of this patient group. The trial will focus on patients who have relapsed after initial treatment and will compare the safety and efficacy of tafenoquine against a placebo, in conjunction with standard care.

The study will involve at least 24, possibly up to 33, hospitalized patients diagnosed with relapsing babesiosis. The primary endpoints of the study are the time to achieve sustained clinical resolution of symptoms and the time to molecular cure, determined through an FDA-approved nucleic acid test (NAT). The trial is structured to allow for an interim analysis, which will include tests of significance and potential adjustments in recruitment numbers if necessary. This analysis will ensure all subjects are enrolled before the end of the 2025 tick season, which traditionally spans from June to September.

Recent medical literature has suggested that combining tafenoquine with standard treatments may result in high cure rates for immunosuppressed patients experiencing relapsing babesiosis. The accessibility of tafenoquine through the end of its U.S. patent protection in December 2035 presents a market opportunity covering approximately 400,000 patients.

Tafenoquine, known commercially as ARAKODA®, is already approved in the United States for malaria prophylaxis. Its safety profile has been well-documented through several randomized, double-blind, placebo-controlled trials. However, its effectiveness for treating or preventing babesiosis has not been established, and it is not yet approved by the U.S. Food and Drug Administration for this use.

The Tafenoquine for Babesiosis study will explore the potential benefits of this 8-aminoquinoline drug, which includes tafenoquine and primaquine, for the treatment of babesiosis. Although there are several case reports of tafenoquine being used for babesiosis in clinical practice, this trial aims to provide more definitive evidence of its efficacy and safety in a controlled setting.

The planned clinical trial offers hope for better management of babesiosis, particularly for patients who have failed to respond to existing treatments. By partnering with leading medical centers, 60 Degrees Pharmaceuticals aims to advance understanding and potential therapy for this challenging tick-borne disease.