60 Degrees Pharma to report babesiosis trial data in January 2027
60 Degrees Pharmaceuticals has announced it will conclude enrolment in its randomised trial of tafenoquine in hospitalised babesiosis patients at 30 subjects, three short of the originally planned 33, and expects to report primary and secondary endpoint results in January 2027. The Washington DC-based company will simultaneously request a pre-supplemental New Drug Application (sNDA) meeting with the FDA to map out a regulatory pathway for what would be the first approved treatment for human babesiosis.
The study, a double-blind, placebo-controlled multisite trial (NCT06207370), evaluated oral tafenoquine added to standard of care at sites including Tufts Medical Center, Yale University, Brigham and Women's Hospital and Rhode Island Hospital. The Data Safety Monitoring Board conducted a scheduled interim analysis on 1 October 2026 and recommended completing enrolment to the planned 33 patients; however, 60 Degrees judged that the marginal statistical gain from three additional subjects did not justify delaying unblinding by up to a year due to babesiosis's tick-driven seasonal pattern. The DSMB found no safety signals at the interim review.
The regulatory case
Even if the severe babesiosis trial falls short of its endpoints, 60 Degrees believes a separate regulatory route remains viable. The company has confirmed molecular cure in the first three patients enrolled in an expanded access study of tafenoquine combined with atovaquone-containing regimens in relapsing, treatment-refractory babesiosis (NCT06478641), using a highly sensitive nucleic acid amplification test. Interim data from two additional expanded access patients are expected in early November 2026.
Should the pivotal trial data package prove insufficient on its own, the company intends to ask the FDA to accept NAT-based molecular clearance as a surrogate endpoint reasonably likely to predict clinical benefit, potentially supporting an accelerated approval route. A post-approval confirmatory study would be proposed alongside any such submission. Accelerated approval on the basis of a surrogate endpoint is established FDA precedent in rare and serious infectious disease, and the agency has shown willingness in recent years to accept nucleic acid clearance measures in parasitic and viral settings, though each case is evaluated individually.
Market context and competitive landscape
No FDA-approved treatment or vaccine exists for babesiosis in humans. The condition, caused by intraerythrocytic Babesia parasites transmitted by ticks and often co-occurring with Lyme disease, has historically been managed with off-label combinations of atovaquone and azithromycin. The CDC has flagged rising emergency department visits for tick bites across the northeastern United States, and the incidence of treatment-refractory cases is drawing increasing attention from infectious disease specialists, particularly as immunosuppressed patient populations grow.
Tafenoquine is already FDA-approved under the ARAKODA brand for malaria prevention, a fact that gives 60 Degrees an established safety and manufacturing dossier on which to draw for any sNDA filing. The company currently has three active babesiosis trials, a relatively concentrated pipeline for a small-cap organisation that the going-concern note in its most recent annual report underscores as carrying execution risk.
No other company appears to be pursuing a New Drug Application or supplemental filing specifically for babesiosis at this stage, though academic groups and larger infectious disease players have shown interest in the tick-borne disease space as case counts rise. For 60 Degrees, a successful readout in January would mark the first prospective randomised efficacy data in hospitalised babesiosis, a milestone with potential to attract partnership interest or support a standalone commercial strategy for its existing ARAKODA franchise.