60 Degrees Pharmaceuticals enrolls first patient in tafenoquine babesiosis trial
60 Degrees Pharmaceuticals Inc. (NASDAQ: SXTP) has enrolled the first patient of the 2026 tick season in its clinical trial evaluating tafenoquine for treating babesiosis in hospitalized patients, according to a company statement.
The randomized, double-blind, placebo-controlled trial (NCT06207370) is being conducted at five clinical sites in the northeastern United States. The study will enroll at least 24 patients before conducting an interim analysis, with two primary endpoints: time to clinical symptom resolution and parasite clearance.
Enrollment is proceeding approximately one month ahead of schedule, which could allow the company to reach minimum enrollment for interim analysis as early as July 2026. The company plans to announce the date for interim analyses approximately 50 days after enrollment completion.
Babesiosis is a tick-borne illness caused by Babesia parasites that multiply in red blood cells. The disease often occurs alongside Lyme disease and can cause fever, chills, sweats and fatigue. Severe cases can be life-threatening in elderly and immunosuppressed patients.
Tafenoquine is currently approved in the United States as ARAKODA for malaria prevention. The drug has not been proven effective for babesiosis treatment and lacks FDA approval for this indication.
The trial compares tafenoquine versus placebo in patients hospitalized for babesiosis who are also receiving standard treatment with atovaquone and azithromycin. The study design includes interim analyses for both primary endpoints and potential sample size re-estimation based on initial results.
