Clinical TrialJul 1, 2026, 08:03 AM
60 Degrees Pharma B-Free Babesiosis Study Recommended for Continuation
AI Summary
60 Degrees Pharmaceuticals announced that the independent Data Safety Monitoring Board (DSMB) has recommended the continuation of its B-Free chronic babesiosis study (NCT06656351). This recommendation follows a review of safety data from the first six patients through Day 30. The B-Free study is evaluating the ARAKODA® regimen of tafenoquine for recovery from severe persistent fatigue in patients with babesiosis, a condition for which no FDA-approved treatment currently exists.
Key Highlights
- DSMB recommended continuation of B-Free babesiosis study.
- Study evaluates ARAKODA® regimen for chronic babesiosis.
- Safety data reviewed from first 6 patients through Day 30.
- Primary endpoint: fatigue resolution at Day 90 vs. baseline.
- B-Free study aims to enroll up to 100 patients.
- No FDA-approved treatment exists for babesiosis.
- ARAKODA® is FDA-approved for malaria prophylaxis.
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