WASHINGTON, July 29, 2026
60 Degrees Pharmaceuticals, Inc. announced that it has successfully enrolled the minimum 24 patients required to initiate an interim analysis in its ongoing Phase 2 randomized, double-blind, placebo-controlled clinical trial evaluating tafenoquine for the treatment of hospitalized patients with severe babesiosis. The company confirmed that the Data Safety and Monitoring Board (DSMB) will review the interim data, with results expected no later than October 6, 2026, while patient enrollment continues. Based on the interim findings, 60 Degrees Pharmaceuticals plans to request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for a potential supplemental New Drug Application (sNDA) for tafenoquine in babesiosis. The study addresses a significant unmet medical need, as there are currently no FDA-approved drugs or vaccines specifically indicated for babesiosis, a serious tick-borne parasitic disease that can cause life-threatening illness in hospitalized patients.
Interim Analysis Could Shape Regulatory Strategy
The ongoing multicenter study, titled “Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis” (NCT06207370), is being conducted across several leading U.S. medical centers, including Tufts Medical Center, Rhode Island Hospital, Yale University, Brigham and Women’s Hospital, and Westchester Medical Center. The DSMB will evaluate the study’s primary endpoint, time to sustained clinical recovery, along with the key secondary endpoint, time to molecular clearance of Babesia parasites. If the interim analysis demonstrates statistically significant improvement in the primary endpoint, the trial may be stopped early due to efficacy. Alternatively, the DSMB may recommend continuing enrollment, expanding the study population, or discontinuing the trial if meaningful clinical benefit is not observed. Following the interim review, the company intends to engage with the FDA to determine the clinical data requirements needed to support a future regulatory submission for babesiosis.
Tafenoquine Targets an Important Unmet Need
Tafenoquine is an investigational therapy for babesiosis, although it is already approved in the United States under the brand name ARAKODA® for the prevention of malaria in adults. Originally discovered by the Walter Reed Army Institute of Research, tafenoquine received FDA approval for malaria prophylaxis in 2018 and is also marketed in Australia as KODATEF®. The medicine’s long elimination half-life of approximately 16 days allows for less frequent dosing compared with traditional malaria prevention therapies. In the current babesiosis study, investigators are evaluating whether tafenoquine, when combined with standard-of-care treatment, can accelerate recovery and improve parasite clearance in patients with severe disease. If successful, the program could provide the first FDA-approved therapy specifically indicated for babesiosis, addressing an area where effective treatment options remain limited despite increasing disease incidence in endemic regions.
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Clinical Progress Strengthens Infectious Disease Pipeline
The enrollment milestone represents an important advancement in 60 Degrees Pharmaceuticals’ strategy to expand the clinical utility of tafenoquine beyond malaria prevention into additional vector-borne infectious diseases. By reaching the predefined enrollment threshold for interim analysis, the company moves closer to generating pivotal clinical evidence that could support future regulatory discussions and potential label expansion. Positive interim results could accelerate the development timeline while reinforcing tafenoquine’s potential role in treating severe babesiosis. As enrollment continues and the October 2026 interim data readout approaches, investors, clinicians, and infectious disease specialists will closely monitor the trial’s outcomes, which could significantly influence the future treatment landscape for this serious and currently underserved parasitic infection.
Source: 60 Degrees Pharmaceuticals, press release
