60 Degrees Pharmaceuticals, Inc. announced that, following a Type C meeting held on January 17, 2024 with the US Food and Drug Administration (FDA), the Company will move forward with a pivotal clinical study of tafenoquine in hospitalized babesiosis patients in the U.S. In advance of the meeting, 60P provided to the FDA an information package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients. It also included 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.

60P is now revising the study protocol in light of that feedback, with the goal of initiating patient enrollment in the summer of 2024. Total babesiosis patients in the U.S. may be approximately 47,000 per year based on the observation of 476,000 Lyme infections and an estimated babesiosis co-infection rate of 10 percent. Tafenoquine is approved for malaria prophylaxis in patients aged 18 years and older 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 FDA for such an indication.