60 Degrees Pharmaceuticals Reaches Key Enrollment Milestone In Severe Babesiosis Clinical Trial

60 Degrees Pharmaceuticals has announced that it has enrolled the minimum 24 patients required to begin an interim analysis in its ongoing clinical trial evaluating tafenoquine as a potential treatment for severe babesiosis. The company expects to disclose the results of the interim analysis by October 6, 2026, while patient enrolment in the study will continue during the review period.

The Phase 2 clinical trial is a double-blind, randomised, placebo-controlled, multicentre study designed to evaluate the safety and effectiveness of oral tafenoquine when used alongside the current standard of care for patients hospitalised with severe babesiosis. The study is being conducted at several leading medical centres across the United States, including Tufts Medical Center, Rhode Island Hospital, Yale University, Brigham and Women's Hospital, and Westchester Medical Center.

The interim analysis will be conducted by an independent Data Safety Monitoring Board (DSMB), which will assess the study's primary endpoint of sustained clinical recovery and the key secondary endpoint of molecular clearance of *Babesia* parasites. If the treatment demonstrates statistically significant benefits for the primary endpoint, the trial could be stopped early. Alternatively, the DSMB may recommend enrolling additional patients or ending the study if the results indicate that achieving statistical significance is unlikely.

Following the interim analysis, 60 Degrees Pharmaceuticals plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the data requirements for a potential supplemental New Drug Application (sNDA), depending on the study's outcome. The company believes the discussions could help determine the next regulatory steps for tafenoquine in the treatment of severe babesiosis.

Babesiosis is a tick-borne disease for which there are currently no FDA-approved treatments or vaccines specifically indicated. Tafenoquine has not yet been approved for the treatment or prevention of babesiosis. However, the medicine is already approved in the United States under the brand name ARAKODA® for the prevention of malaria, providing the company with an established foundation as it explores the drug's potential in additional infectious disease indications.

The completion of the enrolment milestone marks an important step in the development of tafenoquine for severe babesiosis. The upcoming interim analysis is expected to provide valuable clinical data that could influence the future direction of the programme and potentially support regulatory discussions aimed at expanding treatment options for patients with this serious tick-borne infection.