60 Degrees selects Icahn School of Medicine as central site for Phase II study

60 Degrees Pharmaceuticals (SXTP) signed a clinical trial agreement with the Icahn School of Medicine at Mount Sinai in New York City as the central site for a Phase II clinical study of tafenoquine in treating chronic babesiosis. For the purposes of the study, chronic babesiosis is defined as a patient with disabling fatigue of at least six months duration, with other symptoms, and laboratory confirmation of, babesiosis. The open-label study will evaluate the efficacy and safety of the ARAKODA regimen over 90 days, treating patients with a presumptive diagnosis of chronic babesiosis. The primary endpoint will be resolution of fatigue assessed using a patient reported outcome measure at Day 90 compared with baseline. Participants will have experienced significant functional impairment for at least six months. Tafenoquine will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the United States Food and Drug Administration for such an indication.