60 Degrees Pharmaceuticals Announces Clinical Site Now Open for Patient Enrollment for the B-FREE Chronic Babesiosis Study at Mount Sinai Icahn School of Medicine

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]