By Chris Wack

60 Degrees Pharmaceuticals said that following a Type C meeting held Wednesday with the Food and Drug Administration, it will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S.

In advance of the meeting, 60 Degrees provided to the FDA an information package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients, as well as a detailed outline of the proposed study protocol.

The FDA indicated in remarks during the meeting that the proposed study could be sufficient for regulatory approval, provided the company uses a clinical endpoint rather than a surrogate marker.

60 Degrees is now revising its study protocol in light of that feedback, with the goal of initiating patient enrollment in the summer of 2024.

Tafenoquine is approved for malaria prophylaxis in patients 18 years and older in the U.S. under the product name Arakoda. Tafenoquine hasn't been proven to be effective for treatment or prevention of babesiosis and isn't approved by the FDA for such an indication.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 22, 2024 09:19 ET (14:19 GMT)