60 Degrees Pharmaceuticals Submits Breakthrough Therapy Request to FDA

60 Degrees Pharmaceuticals has submitted a Breakthrough Therapy Designation request to the FDA for tafenoquine in relapsing babesiosis in immunosuppressed patients. The first patient to complete the trial regimen has tested negative for babesiosis. The study is intended to confirm the high cure rate reported by Yale in 2024. The Company plans to request a Type B meeting with the FDA in early 2026 to discuss requirements for a supplementary New Drug Application. Remaining patients will complete the study between January and October 2026.

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP) has submitted a Breakthrough Therapy Designation request to the U.S. Food and Drug Administration (FDA) for tafenoquine in the treatment of relapsing babesiosis in immunosuppressed patients. The announcement comes on the heels of positive results from the company's expanded access study, which has shown promising outcomes for patients with the tick-borne illness.

The first patient to complete the trial regimen tested negative for babesiosis using both the Mayo Clinic RT-PCR and an FDA-licensed RNA amplification assay, which is at least 100 times more sensitive than standard RT-PCRs. This is a significant milestone, as babesiosis is a life-threatening disease that frequently relapses in immunosuppressed patients, and there are currently no FDA-approved treatments or vaccines available.

The study, an open-label, expanded access, multi-site trial evaluating the safety and efficacy of tafenoquine combined with standard of care medications, aims to confirm the high cure rate reported by Yale in a 2024 Clinical Infectious Diseases publication. The remaining patients enrolled in the study are expected to complete the trial between January and October 2026, with clinical data anticipated in the second half of 2026.

60 Degrees Pharmaceuticals plans to request a Type B meeting with the FDA in early 2026 to discuss requirements for a supplementary New Drug Application (sNDA). Tafenoquine, currently approved for malaria prophylaxis under the brand name ARAKODA®, is not yet approved by the FDA for the treatment and prevention of babesiosis.

The company's efforts to develop a treatment for babesiosis come at a critical time, as the 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 or individuals who have been administered immunosuppressive drugs. The long terminal half-life of tafenoquine offers the advantage of less frequent dosing for the prophylaxis of malaria, which could potentially be beneficial for the treatment of babesiosis as well.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The company achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018. ARAKODA® is commercially available in the U.S. and Australia.