60 Degrees Pharmaceuticals, a Washington, D.C.-based company developing medicines for vector-borne disease, announced on October 6, 2026 that it will conclude enrollment in its randomized clinical study of tafenoquine in patients hospitalized with severe babesiosis at 30 patients. The company plans to unblind the study and report primary and secondary endpoint results in January 2027, and to request a pre-supplemental New Drug Application (sNDA) meeting with the U.S. Food and Drug Administration (FDA) the same month.
There is currently no FDA-approved treatment or vaccine for human babesiosis. Tafenoquine is approved as ARAKODA® for malaria prevention but is not approved for the treatment or prevention of babesiosis.
Why Enrollment Is Ending at 30 Patients
The double-blind, randomized, multisite, placebo-controlled study (NCT06207370) is evaluating tafenoquine plus standard of care versus placebo plus standard of care. Patients were enrolled at sites including Tufts Medical Center, Rhode Island Hospital, Yale University, Brigham and Women’s Hospital, and Westchester Medical Center.
On October 1, 2026, the study’s Data Safety Monitoring Board (DSMB) completed a scheduled interim analysis of the primary endpoint, time to sustained clinical resolution, and a key secondary endpoint, time to molecular clearance of Babesia parasites. The DSMB recommended completing the originally planned enrollment of 33 patients and identified no safety issues. The study remains blinded.
With 30 patients enrolled, 60 Degrees decided to proceed with final analysis. The company cited the limited added statistical power of three more patients and the seasonal nature of babesiosis, which could otherwise delay unblinding until fall 2027. The company notes that the DSMB’s recommendation does not establish whether the study met its endpoints. Those results will be determined after unblinding and final analysis.
Early Signals in Treatment-Refractory Disease
A growing body of published case reports suggests that tafenoquine, combined with atovaquone-containing regimens for at least eight weeks, may achieve a high cure rate in high-risk patients with treatment-refractory, relapsing babesiosis. Consistent with those reports, 60 Degrees has confirmed molecular cure, using a highly sensitive nucleic acid amplification test (NAT), in the first three patients enrolled in its expanded access study in this population (NCT06478641). Final screening data from two additional patients are expected in early November 2026.
The Regulatory Path Ahead
Regardless of the January results, the company believes an approval pathway based on case reports in the treatment-refractory population is possible. At its pre-sNDA meeting, 60 Degrees plans to discuss data requirements, the patient population, the regulatory pathway, and post-marketing requirements. If the data package relies on published literature and expanded access cases alone, the company plans to ask the FDA to consider NAT-based molecular clearance as a surrogate endpoint reasonably likely to predict clinical benefit, potentially supporting accelerated approval, along with a post-approval confirmatory study. The availability of that pathway and the adequacy of any submission will be subject to FDA review.
About Babesiosis
Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells, often occurring as a co-infection with Lyme disease. Symptoms include fever, chills, sweats, and fatigue. In severely immunocompromised patients, standard antimicrobial regimens can fail to clear infection, leading to relapsing disease that may persist for months or years. Incidence is rising rapidly, particularly in the Northeast.
About 60 Degrees Pharmaceuticals
Founded in 2010, 60 Degrees Pharmaceuticals develops and commercializes medicines for the treatment and prevention of vector-borne disease. Its lead product, ARAKODA® (tafenoquine), was approved by the FDA for malaria prevention in 2018 and is sold in the U.S. and Australia. The company currently has three active clinical trials in babesiosis and is headquartered in Washington, D.C., with a subsidiary in Australia.
