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60 Degrees Pharmaceuticals Unveils Name of Chronic Babesiosis Clinical Trial: B-FREE Chronic Babesiosis Study

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  • 60 Degrees Pharmaceuticals, Inc. announced the B-FREE Chronic Babesiosis Study (NCT06656351) as the name for its Phase 2 trial, selected via a nationwide social media naming competition with patient input.
  • The company donated $5,000 to the Global Lyme Alliance (GLA) & the International Lyme and Associated Diseases Education Foundation (ILADEF) to recognize the winning name.
  • The B-FREE trial is the first in the world to evaluate tafenoquine (ARAKODA) for chronic babesiosis & will commence in early November 2025 for approximately 12 months.
  • The open-label study will assess the efficacy & safety of a 90-day tafenoquine regimen in up to 100 patients to determine resolution of severe fatigue & parasite eradication.
  • No FDA-approved drug or professional society-recommended treatment currently exists for chronic babesiosis.
  • Tafenoquine is currently approved in the U.S. only for malaria prophylaxis under the brand name ARAKODA & has not been proven effective for babesiosis treatment or prevention.
  • The study aims to estimate infection confirmation rates using the FDA-approved RNA amplification test & compare them against commercially available CLIA-validated RT-PCR assays.
  • Chronic babesiosis is described as a potentially disabling condition transmitted by the black-legged tick, with incidence rapidly rising in the Northeast.
  • ARAKODA carries significant safety warnings including contraindications for patients with G6PD deficiency, history of psychotic disorders, or hypersensitivity to 8-aminoquinolines.
  • The trial is funded by the United States Army Medical & Materiel Development Activity & tafenoquine was originally discovered by the Walter Reed Army Institute of Research.