Core Insights - 60 Degrees Pharmaceuticals, Inc. has initiated patient enrollment for the B-FREE Chronic Babesiosis Study, the first of its kind to evaluate a therapeutic for chronic babesiosis, which is expected to run for approximately 12 months [1][5][7] Study Overview - The B-FREE Chronic Babesiosis Study (NCT06656351) is a Phase 2 open-label study assessing the efficacy and safety of the ARAKODA® regimen of tafenoquine over 90 days for patients with chronic babesiosis [2][6] - Chronic babesiosis is characterized by disabling fatigue lasting at least six months, with laboratory confirmation of Babesia parasite exposure within the last year [3][4] - The study aims to confirm Babesia infection using validated molecular tests, potentially revealing a patient population size that could range from 4,400 to 190,000 cases annually in the U.S. [4][7] Treatment Details - The primary endpoint of the study is the resolution of fatigue, measured at Day 90 compared to baseline, using a patient-reported outcome measure [6][7] - The treatment regimen involves self-administering tafenoquine (2 x 100 mg tablets) orally with food for a total of 12 weeks [6][7] Market Need - There is currently no FDA-approved treatment for babesiosis, highlighting a significant unmet medical need [4][15] - The incidence of babesiosis is rising, particularly in the Northeast U.S., with estimates suggesting at least 25,000 cases annually, though the true number may be much higher [15][30] Company Background - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for vector-borne diseases and achieved FDA approval for ARAKODA® (tafenoquine) for malaria prevention in 2018 [30][18] - The company collaborates with research and academic organizations in the U.S. and Australia, and is headquartered in Washington, D.C. [30]

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]