60 Degrees Pharmaceuticals, Inc. announced the approval of an Investigational Review Board (IRB) 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 (FDA) 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. The safety of the approved regimen of tafenoquines 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. The Phase IIA study, titled, "Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis," is anticipated to enroll at least 24 patients in the U.S., beginning in Second Quarter 2024. The primary endpoint of the study will be time to molecular cure as determined by an FDA-approved nucleic acid test (NAT). The study will be conducted at three hospitals in the northeastern United States. Use in Specific Populations: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of 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. The Phase IIA study, titled, ?Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral
Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis,?
is anticipated to enroll at least 24 patients in the U.S., beginning in Second Quarter 2024. The primary endpoint of the
study will be time to molecular cure as determined by an FDA-approved nucleic acid test (NAT). The study will be conducted at three hospitals in the northeastern United States. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established. The appearance of several case studies of tafenoquine use for babesiosis in the literature suggests that the drug is being used for this purpose in the practice of medicine in the U.S. An estimated 47,000 cases of babesiosis (i.e., infections caused by red blood cell parasites similar to malaria that are transmitted by deer tick bites) occur in the United States each year and the incidence rate is steadily increasing. An estimated 10% of Lyme disease patients are co-infected with babesiosis. The mortality rate of babesiosis patients who have cardiac complications approaches 10%. Babesiosis is spread by the bite of an infected blacklegged tick, Ixodes scapularis. It can also be spread by transfusion of contaminated blood. Anyone can get babesiosis, but it can be more severe in the elderly, people who have had their spleen removed, and in people who have weakened immune systems (for example, those who have cancer, HIV/AIDS, or a transplant). Most cases occur in coastal areas in the Northeast and upper Midwest, particularly in parts of New England, New York State, New Jersey, Wisconsin, Minnesota and in some European countries. In the Northeast, babesiosis occurs in both inland and coastal areas, including offshore islands such as Nantucket and Martha?s Vineyard, which are off Massachusetts, as well as in Long Island and the Hudson Valley in New York State. Hospitalizations as a result of babesiosis are usually seasonal, occurring June through August. Clinical complications include severe anemia, renal failure, cardiorespiratory failure, and death. Babesiosis was designated a nationally notifiable disease in the United States in 2011, meaning that states where it was reportable were charged to voluntarily notify the Centers for Disease Control and Prevention (CDC) of cases. As of 2015, babesiosis was reportable in 33 states. Tafenoquine was discovered by Walter Reed Army Institute of Research and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.