60 Degrees Pharmaceuticals, Inc. announced that the first patient has been enrolled in a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of tafenoquine in treating babesiosis in humans. The patient was enrolled at Tufts Medical Center in Boston. The study will enroll at least 24, and as many as 33 people.

It is the world's first and only clinical trial evaluating the efficacy and safety of tafenoquine in human patients who have been diagnosed with acute babesiosis. Babesiosis is a steadily emerging, tick-borne disease transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease. An orphan disease, babesiosis may be life-threatening in elderly and immunosuppressed patients.

The Company is in discussions with other prominent university hospitals to participate in the tafenoquine for babesiosis study. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months.

Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.