WASHINGTON, DC — 60 Degrees Pharmaceuticals, Inc. , a pharmaceutical company focused on developing new medicines for infectious diseases, announced today 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. 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.
About the Phase IIA Tafenoquine for Babesiosis Study
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 Q2 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.
About ARAKODA® (tafenoquine)
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.
According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA is not suitable for everyone, and patients and prescribers should review the Important Safety Information below.
Individuals at risk of contracting malaria are prescribed ARAKODA 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60P successfully achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60P also collaborates with prominent research organizations in the U.S., Australia, and Singapore. 60P’s mission has been supported through in-kind funding from the DOD and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60P is headquartered in Washington D.C., with a majority-owned subsidiary in Australia.
Sheila A. Burke