Компания 60 Degrees Pharmaceuticals
60 Degrees Pharmaceuticals Announces No Detection of Babesia Infection in First Patient Following Treatment with Tafenoquine in Relapsing Babesiosis Study
WASHINGTON -- 60 Degrees Pharmaceuticals, Inc., a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced that the first patient to have completed the regimen in the Company’s trial of relapsing babesiosis in immunosuppressed patients has tested negative for babesiosis. The trial is an expanded access study of ARAKODA® (tafenoquine) in combination with conventional treatments for relapsing babesiosis (NCT06478641).
Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Symptoms include fevers, chills, sweats, and fatigue. In severe cases, babesiosis can be life-threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. The disease may relapse multiple times in patients with risk factors such as asplenia (no spleen) or individuals who have been administered immunosuppressive drugs. Babesia parasites frequently develop resistance to conventional drugs when they are used persistently to manage disease in such patients.
No U.S. Food and Drug Administration (FDA)-approved treatment or vaccine exists for babesiosis.
The Company’s study aims to confirm the high cure rate for tafenoquine in enrolled immunosuppressed patients with relapsing babesiosis, as reported by Yale in a 2024 Clinical Infectious Diseases publication. It is an open label, expanded access, multi-site study evaluating the safety and efficacy of the ARAKODA® regimen of tafenoquine combined with standard of care medications in patients with risk factors for severe disease with relapsing babesiosis who have previously failed conventional antimicrobial regimens.
Sixty days following clinical resolution and cessation of study drug administration, the study protocol calls for a follow-up visit at which two molecular tests are administered to assess parasite infection status. One test is an RT-PCR from Mayo Clinic. The second is an FDA-approved RNA amplification test used for blood donation screening that is at least 100 times more sensitive than standard commercial RT-PCRs such as the Mayo test. Since blood donation screening using RNA amplification tests commenced in 2020, the number of babesiosis infections contracted through the U.S. blood donation system has declined precipitously.
The first patient in the 60 Degrees expanded access relapsing babesiosis study tested negative for babesiosis infection using both the Mayo and RNA amplification assays.
On October 3, 2025, the Company submitted a Breakthrough Therapy Application to the FDA for use of tafenoquine for treatment of babesiosis patients requiring medical treatment. The remaining patients now enrolled are anticipated to complete the study between January and October, 2026.
