Core Insights - 60 Degrees Pharmaceuticals, Inc. has announced the B-FREE Chronic Babesiosis Study, the first trial globally to evaluate a potential new treatment for chronic babesiosis [1][2] - The study will assess the efficacy and safety of the ARAKODA regimen of tafenoquine over a 90-day period for patients suffering from chronic babesiosis [2][6] - Currently, there are no FDA-approved treatments for chronic babesiosis, highlighting the significance of this study [3][10] Company Overview - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for its lead product, ARAKODA, in 2018 [24] - The company is headquartered in Washington, D.C., and collaborates with research and academic organizations in the U.S. and Australia [24] Study Details - The B-FREE study is a Phase 2 open-label trial expected to last approximately 12 months, enrolling up to 100 patients diagnosed with chronic babesiosis [2][7] - The primary endpoint is the resolution of fatigue, measured at Day 90 compared to baseline, with participants having experienced significant functional impairment for at least six months [6][7] - Tafenoquine, the active ingredient in ARAKODA, is currently approved for malaria prophylaxis but has not been proven effective for babesiosis treatment [5][12] Patient Engagement - The naming of the B-FREE study involved direct engagement with the tick-borne disease patient community, reflecting the company's commitment to patient involvement in research [4][5] - A total of $5,000 was donated to the Global Lyme Alliance and the International Lyme and Associated Diseases Education Foundation as part of this initiative [4] Public Health Context - Chronic babesiosis is a growing public health concern, particularly for vulnerable populations such as the elderly and immunocompromised individuals [5][10] - The incidence of babesiosis is rising, with an estimated minimum of 25,000 cases annually in the U.S., although the actual number may be significantly higher [10]