60 Degrees Pharmaceuticals picks Mount Sinai for babesiosis trial

60 Degrees Pharmaceuticals Inc. (NASDAQ: SXTP) has selected the Icahn School of Medicine at Mount Sinai as the central clinical trial site for a Phase II study evaluating tafenoquine for chronic babesiosis treatment.

The 90-day open-label study will measure changes in general fatigue among chronic babesiosis patients. Enrollment is expected to begin in the fourth quarter of 2025 and complete by the second quarter of 2026.

The study defines chronic babesiosis as patients with disabling fatigue lasting at least six months, accompanied by other symptoms and laboratory confirmation of babesiosis. The primary endpoint will assess fatigue resolution using a patient-reported outcome measure at Day 90 compared to baseline.

Participants will receive tafenoquine as two 100 mg tablets taken orally with food on Days 1-4, then weekly for 12 weeks total. Weekly treatment begins on Day 11 and ends on Day 89.

Tafenoquine is currently approved for malaria prevention in the United States under the brand name ARAKODA. The drug has not been proven effective for babesiosis treatment or prevention and lacks FDA approval for this indication.

The company is conducting three clinical trials to evaluate tafenoquine's safety and efficacy for babesiosis treatment. Data from one or more studies is expected in the first half of 2026 and will support a planned New Drug Application submission to the FDA for babesiosis treatment in 2026.

Babesiosis is a tick-borne illness caused by parasites that multiply in red blood cells. The disease has no FDA-approved treatment and is transmitted through black-legged tick bites, the same vector that spreads Lyme disease. Symptoms include fever, chills, sweats and fatigue, with the latter potentially lasting over a year in some patients.

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