60 Degrees Pharmaceuticals opens site for chronic babesiosis study

60 Degrees Pharmaceuticals Inc. (NASDAQ: SXTP) announced the opening of patient enrollment at Mount Sinai Icahn School of Medicine for its B-FREE chronic babesiosis study. The Phase 2 trial will evaluate tafenoquine treatment over 90 days in patients with chronic babesiosis, measuring changes in general fatigue.

The study will enroll up to 100 patients and run for approximately 12 months. Chronic babesiosis is defined as disabling fatigue lasting at least six months with other babesiosis symptoms and laboratory confirmation of Babesia parasite exposure within 12 months. No FDA-approved treatment currently exists for babesiosis.

The company estimates the unmet medical need ranges from 4,400 to 190,000 cases annually in the United States. The B-FREE study aims to establish whether Babesia infection can be confirmed using validated molecular tests in patients with chronic babesiosis diagnoses.

The primary endpoint measures resolution of fatigue using a patient-reported outcome measure at Day 90 compared to baseline. Participants will take tafenoquine tablets daily for four days, then weekly for 12 weeks total.

Tafenoquine is currently approved for malaria prophylaxis under the brand name ARAKODA but has not been proven effective for babesiosis treatment or prevention. The drug is not approved by the FDA for babesiosis indications.

60 Degrees Pharmaceuticals is conducting two additional tafenoquine studies for babesiosis. One randomized trial in hospitalized patients has enrolled 19 of the required 24 patients. An expanded access study for high-risk patients has one completed participant and two ongoing.

The company plans to request a Type B meeting with the FDA in early 2026 to discuss requirements for submitting a supplemental New Drug Application.

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