60 Degrees Pharma Announces IRB Approval of Clinical Study of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients with Persistent Babesia microti Despite Prior Treatment

Company Overview - 60 Degrees Pharmaceuticals, Inc. was founded in 2010 and focuses on developing and marketing new medicines for infectious diseases [1] - The company achieved FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018 [1] - 60 Degrees Pharmaceuticals collaborates with prominent research organizations in the U.S., Australia, and Singapore [1] - The company is headquartered in Washington D.C. and has a majority-owned subsidiary in Australia [1] Product Information - ARAKODA® (tafenoquine) is approved for malaria prophylaxis in the U.S. and Australia, with commercial launches occurring in 2019 [6] - Tafenoquine has not been proven effective for the treatment or prevention of babesiosis and is not FDA-approved for this indication [8][11] Recent Developments - The company announced ethics approval for an open label, expanded access study of the ARAKODA® regimen in immunosuppressed patients with persistent/relapsing babesiosis [7] - The goal of the study is to confirm an 80% cure rate for babesiosis observed in a previous case series conducted by Yale School of Public Health [12] - The total accessible market for ARAKODA in babesiosis is estimated at 38,000 acute patients and at least 375,000 chronic patients in the U.S. [10] Clinical Trials - 60 Degrees Pharmaceuticals is advancing multiple clinical trials to establish the safety and efficacy of tafenoquine for babesiosis [14] - The trials include studies for hospitalized acute babesiosis patients, expanded access for persistent disease, and chronic babesiosis [15] - A New Drug Application with the FDA for a supplemental indication for tafenoquine in babesiosis is planned for the second quarter of 2026 [15]