60 Degrees Pharmaceuticals reports first patient clears babesia infection

60 Degrees Pharmaceuticals Inc. (NASDAQ: SXTP) announced that the first patient in its relapsing babesiosis study tested negative for babesia infection following treatment with tafenoquine combined with conventional therapies.

The patient completed the treatment regimen in the company's expanded access study evaluating ARAKODA (tafenoquine) for relapsing babesiosis in immunosuppressed patients. Results were obtained using two molecular tests, including an FDA-approved RNA amplification test used for blood donation screening that is reportedly 100 times more sensitive than standard commercial RT-PCR tests.

Babesiosis is a tick-borne illness caused by parasites that multiply in red blood cells. The disease can be life-threatening in elderly and immunosuppressed patients and may relapse multiple times in patients with risk factors such as absence of a spleen or those receiving immunosuppressive drugs. No FDA-approved treatment currently exists for babesiosis.

The study aims to confirm efficacy rates for tafenoquine in immunosuppressed patients with relapsing babesiosis, based on a 2024 Yale publication in Clinical Infectious Diseases. The remaining enrolled patients are expected to complete the study between January and October 2026.

On October 3, 2025, the company submitted a Breakthrough Therapy Application to the FDA for tafenoquine treatment of babesiosis patients requiring medical treatment. The company plans to request a Type B meeting with the FDA in early 2026 to discuss requirements for a supplementary New Drug Application.

Tafenoquine is currently approved in the United States as ARAKODA for malaria prophylaxis but is not approved for babesiosis treatment or prevention. The drug was discovered by Walter Reed Army Institute of Research and received initial FDA approval for malaria prevention in 2018.

The company is conducting three clinical trials to evaluate tafenoquine's safety and efficacy in treating babesiosis, with data expected from one or more studies in the second half of 2026.

You May Also Be Interested In

• Berenberg Downgrades Novo Nordisk (NVO) to Hold
• FDA grants priority review to Belite Bio's Stargardt disease drug
• SINTX Technologies issues revenue outlook and mid-year update