60 Degrees Pharmaceuticals Achieves Early Enrollment Milestone in Tafenoquine Babesiosis Trial

Enrollment running approximately one month ahead of schedule in 60 Degrees Pharmaceuticals' tafenoquine babesiosis trial (NCT06207370) has pulled the interim analysis window forward, with minimum enrollment now projected as early as July 2026, a timeline shift that compresses the data readout cycle for a program targeting an indication with no currently approved treatment.

The randomized, double-blind, placebo-controlled study is enrolling patients hospitalized with babesiosis across five clinical sites in the northeastern United States. The trial requires at least 24 patients before an interim analysis is triggered, with the two primary endpoints, time to sustained clinical symptom resolution and molecular cure confirmed by PCR assay, subject to separate interim analyses as data accumulate. Enrolled patients receive tafenoquine or placebo on top of standard-of-care atovaquone/azithromycin.

Tafenoquine carries FDA approval for malaria prophylaxis under the brand name ARAKODA, granted in 2018 and commercially launched in 2019 through pharmaceutical wholesaler networks. The compound's established manufacturing and distribution infrastructure gives 60 Degrees a practical advantage in running a repurposing program: existing GMP-compliant supply chains reduce the lead time and capital burden that typically constrain small-company clinical programs. Tafenoquine has not been approved by the FDA for babesiosis treatment or prevention, and efficacy in this indication remains unproven pending trial results.

The clinical context is relevant for QA and regulatory leads tracking emerging tick-borne disease programs. The CDC has reported emergency room visits for tick bites are at historically high levels across multiple U.S. regions, and babesiosis, caused by Babesia parasites that replicate within red blood cells, carries serious risk of mortality in elderly and immunosuppressed patients. The disease frequently presents as a co-infection alongside Lyme disease, complicating both diagnosis and treatment protocols at the site level.

Approximately 50 days after enrollment completion, the company intends to announce the planned date for the interim analyses, establishing a measurable checkpoint against which site readiness and data integrity processes should be aligned.

Source: 60 Degrees Pharmaceuticals via GlobeNewswire, May 26, 2026.