60 Degrees reports IRB approval of Phase IIA study of tafenoquine

60 Degrees Pharmaceuticals announced the approval of an Investigational Review Board sanctioned Phase IIA clinical study. The study aims to investigate the efficacy and safety of the ARAKODA regimen of tafenoquine in combination with standard of care medications for treatment of hospitalized babesiosis patients at lower risk of relapse. Additionally, the U.S. Food and Drug Administration rescheduled the Company’s previously announced January 15 Type C meeting to January 17, 2024, due to a federal holiday. The agenda and all material submitted by SXTP to FDA in support of the Type C meeting remain unchanged. Babesiosis is a potentially life-threatening, tick-borne illness steadily emerging in the United States. Total babesiosis patients in the U.S. may be approximately 47,000 per year based on the observation of 476,000 Lyme infections and an estimated babesiosis coinfection rate of 10 percent. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.