On June 27, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine for the treatment of Babesiosis. This trial is the first of its kind globally and aims to enroll between 24 to 33 patients. The study is a randomized, double-blind, placebo-controlled trial with endpoints focusing on the time to sustained clinical resolution of symptoms and molecular cure as determined by an FDA-approved nucleic acid test. Tafenoquine, currently approved for malaria prophylaxis under the name ARAKODA®, has not yet been approved for the treatment or prevention of Babesiosis. However, it has been designated as an orphan drug by the U.S. Food...Show More

On June 27, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine for the treatment of Babesiosis. This trial is the first of its kind globally and aims to enroll between 24 to 33 patients. The study is a randomized, double-blind, placebo-controlled trial with endpoints focusing on the time to sustained clinical resolution of symptoms and molecular cure as determined by an FDA-approved nucleic acid test. Tafenoquine, currently approved for malaria prophylaxis under the name ARAKODA®, has not yet been approved for the treatment or prevention of Babesiosis. However, it has been designated as an orphan drug by the U.S. Food and Drug Administration for this indication. The trial will take place during the 2024 tick season and may expand to include additional university hospitals. The company, which specializes in developing medicines for infectious diseases, has previously achieved FDA approval for ARAKODA® for malaria prevention and is collaborating with research organizations in the U.S., Australia, and Singapore.