Pivotal Clinical Study of Tafenoquine for Hospitalized Babesiosis Patients

By Chris Wack

60 Degrees Pharmaceuticals has announced its plans to move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S. This decision was made following a Type C meeting with the Food and Drug Administration (FDA) on Wednesday.

To prepare for the meeting, 60 Degrees Pharmaceuticals provided the FDA with an information package. The package detailed the unmet medical need for a new therapeutic for hospitalized babesiosis patients and included a comprehensive outline of the proposed study protocol.

During the meeting, the FDA expressed that the proposed study could potentially meet regulatory approval if a clinical endpoint is used instead of a surrogate marker. Taking this feedback into consideration, 60 Degrees Pharmaceuticals is currently revising its study protocol and aims to begin patient enrollment in the summer of 2024.

It's important to note that while tafenoquine is approved for malaria prophylaxis in patients 18 years and older, it has not been proven effective in treating or preventing babesiosis. The FDA has yet to approve tafenoquine for this particular indication.