ARAKODA regimen (tafenoquine) - (open label) - (B-FREE)

July 1, 2026: 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP, SXTPW) reported that an independent Data Safety Monitoring Board recommended continuing the B-FREE open-label chronic babesiosis study (NCT06656351) after reviewing safety data from the first six patients from baseline through Day 30. The trial is evaluating the efficacy and safety of an ARAKODA® (tafenoquine) regimen (200 mg daily for four days, then 200 mg weekly through Day 90) in patients with severe persistent fatigue and laboratory evidence of exposure to Babesia spp.

B-FREE plans to enroll up to 100 patients, with a goal of at least 16 completing the study with Babesia infection confirmed at baseline by validated molecular tests. The primary endpoint is fatigue resolution at Day 90 versus baseline using the multi-dimensional fatigue inventory general fatigue subscale. Participants must have had significant functional impairment for at least six months; testing includes an FDA-licensed RNA amplification test and two CLIA-validated RT-PCR assays at baseline and roughly monthly for six months.

The release notes no FDA-approved treatment or vaccine exists for babesiosis, and tafenoquine is not FDA-approved for babesiosis (it is approved for malaria prophylaxis as ARAKODA®).