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60 Degrees Pharmaceuticals Announces All Patients Cured of Babesiosis After Tafenoquine Treatment in Expanded Use Clinical Trial
All three patients enrolled in study have been cured, confirming high cure rate of tafenoquine in immunosuppressed patients, as reported by Yale in a 2024
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"All three patients enrolled in study have been cured, confirming high cure rate of tafenoquine in immunosuppressed patients, as reported by Yale in a 2024 publicationCompany calls for existing babesiosis treatment guidelines to be reviewed in light of the new data WASHINGTON, March 11, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced that three of three enrolled patients have been cured of babesiosis after completing the tafenoquine regimen in the Company’s trial of relapsing babesiosis in immunosuppressed patients. The Company’s expanded use trial is an open-label, expanded access, multi-site study evaluating the safety and efficacy of the ARAKODA® regimen of tafenoquine combined with atovaquone and other antimalarials/antibiotics administered to patients with risk factors for severe disease with relapsing babesiosis who have previously failed conventional antimicrobial regimens (NCT06478641). It aims to confirm the high cure rate from the addition of tafenoquine in these patients, as reported by the Yale School of Public Health in a 2024 Clinical Infectious Diseases publication. For this study, tafenoquine treatment is continued for up to one year until two consecutive negative PCR tests for Babesia parasites are recorded and symptoms of babesiosis are resolved. Sixty to ninety 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 a U.S. Food and Drug Administration (FDA)-approved RNA amplification test used for blood donation screening that is at least 1,000 times more sensitive than standard commercial RT-PCRs such as the Mayo test. A patient is considered cured if no evidence of infection (i.e., a non-reactive RNA amplification test) is detected following treatment. The Yale study reported an apparent treatment success rate of 100 percent in four patients when an atovaquone-containing standard of care regimen was combined with weekly tafenoquine administered until two sequential non-reactive conventional PCRs were noted. The fifth patient in the Yale stud...