Core Insights - 60 Degrees Pharmaceuticals has announced that the first patient in its trial for relapsing babesiosis has tested negative for the disease, indicating potential efficacy of ARAKODA (tafenoquine) in immunosuppressed patients [1][7] Company Developments - The company is conducting an expanded access study of ARAKODA in combination with conventional treatments for relapsing babesiosis, with the trial expected to confirm a high cure rate as reported by Yale in a 2024 publication [5][9] - A Breakthrough Therapy Designation request has been submitted to the FDA for tafenoquine, and the company plans to request a Type B meeting with the FDA in early 2026 to discuss the requirements for a supplementary New Drug Application (sNDA) [4][8] Clinical Study Details - The study is an open-label, multi-site trial evaluating the safety and efficacy of tafenoquine in patients with risk factors for severe disease who have previously failed conventional treatments [5][9] - The first patient tested negative for babesiosis using both the Mayo Clinic RT-PCR and an FDA-approved RNA amplification test, which is significantly more sensitive than standard tests [6][7] Disease Context - Babesiosis is a tick-borne illness that can be life-threatening, especially in elderly and immunosuppressed patients, with a rising incidence particularly in the Northeast [2] - The disease may relapse in patients with certain risk factors, and Babesia parasites can develop resistance to conventional drugs [2]