60 Degrees Pharmaceuticals Enrolls First Patient in Tafenoquine Expanded Access Clinical Study for Persistent (B. microti) Babesiosis

Clinical Study and Market Potential - The first patient has been enrolled in NCT06478641, an expanded access clinical study to confirm the activity of tafenoquine in treating persistent babesiosis in high-risk patients who have failed standard care [1] - Tafenoquine exhibited an 80% cure rate in five high-risk patients with persistent, relapsing babesiosis who had failed prior standard-of-care treatments [2] - The total cumulative accessible market for ARAKODA (tafenoquine) for babesiosis may exceed 400,000 patients through the end of U.S. patent protection in December 2035 [4][8] Tafenoquine and ARAKODA Overview - Tafenoquine is approved for malaria prophylaxis in the U.S. under the product name ARAKODA and in Australia as KODATEF [6] - ARAKODA is indicated for malaria prophylaxis in patients aged 18 years and older, with a long terminal half-life of approximately 16 days, offering potential advantages in less-frequent dosing [6][7] - Tafenoquine was discovered by Walter Reed Army Institute of Research and commercially launched in 2019 [6] Safety and Adverse Reactions - ARAKODA should not be administered to patients with G6PD deficiency, during pregnancy or lactation, or with a history of psychotic disorders [9][10][11][17] - Common adverse reactions include headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety [13] - Serious hypersensitivity reactions, delayed adverse reactions, and psychiatric effects have been observed with ARAKODA use [12] Company Background - 60 Degrees Pharmaceuticals, founded in 2010, specializes in developing and marketing new medicines for infectious diseases [16] - The company achieved FDA approval of ARAKODA for malaria prevention in 2018 and collaborates with research organizations in the U.S., Australia, and Singapore [16] - The company is headquartered in Washington D.C., with a majority-owned subsidiary in Australia [18]