60 Degrees Pharma hits enrolment trigger in babesiosis tafenoquine trial
60 Degrees Pharmaceuticals has reached the minimum enrolment threshold in its randomised, double-blind, placebo-controlled trial of tafenoquine in hospitalised babesiosis patients, triggering an interim analysis that the company expects to report by 6 October 2026. Enrolment at the five US sites will continue while the data safety and monitoring board conducts its review.
The NASDAQ-listed company (ticker: SXTP) is evaluating oral tafenoquine added to standard of care against placebo plus standard of care in patients with severe babesiosis. The primary endpoint is time to sustained clinical recovery; a key secondary endpoint measures time to molecular clearance of Babesia parasites in the blood. If the interim analysis achieves statistical significance on the primary endpoint, the trial will stop early. If significance is not reached and is considered unlikely with further enrolment, the DSMB could recommend closure.
Clinical and regulatory context
Sites participating in the study include Tufts Medical Center, Rhode Island Hospital, Yale University, Brigham and Women's Hospital, and Westchester Medical Center, reflecting the disease's geographic concentration in the north-eastern United States, where tick-borne Babesia microti infection is endemic.
60 Degrees said it intends to seek an FDA meeting following the interim readout to discuss data requirements for a supplemental New Drug Application. Tafenoquine is already approved in the United States under the brand name ARAKODA for malaria prophylaxis, a status granted in 2018 following work originally conducted by the Walter Reed Army Institute of Research. The company would be seeking to extend that approval into a new indication rather than filing a de novo NDA.
The regulatory framing is noteworthy. Babesiosis currently has no FDA-approved treatment or vaccine, meaning a successful supplemental NDA would fill a genuine unmet medical need, a factor the agency weighs under its Priority Review and Breakthrough Therapy programmes. Whether 60 Degrees will seek either designation has not been disclosed.
Market landscape
The babesiosis treatment space is sparsely populated. Current standard of care relies on combinations of existing anti-infective agents used off-label, most prominently atovaquone plus azithromycin for mild-to-moderate disease, and clindamycin plus quinine for severe cases. No purpose-developed agent is approved, which limits both clinician options and commercial benchmarking for any entrant.
60 Degrees is a small-cap company and the forward-looking sections of its release cite a going-concern qualification in its most recent annual filing, a factor that institutional investors will weigh when assessing the company's ability to fund a full pivotal programme if the interim data require additional enrolment rather than enabling an accelerated regulatory path. The company has not disclosed the size of its cash runway in this announcement.
Tick-borne disease more broadly is attracting growing research attention as range expansion of the black-legged tick pushes Babesia exposure further northward and westward across the United States. A positive interim readout in October would represent a meaningful catalyst for the company and could attract partnership interest from larger infectious-disease franchises looking for bolt-on assets in an underserved area.