Enrollment Milestone

60 Degrees reports all three babesiosis patients cured with tafenoquine regimen

An expanded-access study designed to confirm Yale's reported cure rate for tafenoquine in relapsing babesiosis reported 3 of 3 patients cured, as the sponsor pursues a Breakthrough Therapy request and an NDA path built on this and two other trials.

By AppliedXLJuly 13, 2026Trial NCT06478641

Executive Summary

60 Degrees Pharmaceuticals' expanded-access study of tafenoquine in relapsing babesiosis has completed, and every enrolled patient cleared infection on the most sensitive test available.
The result gives the company a clinical anchor as it pursues a Breakthrough Therapy request and plans a new drug application in a disease with no approved treatment.
The cohort behind this result is small, and the study was open-label without a control arm, so the finding is supportive rather than decision-grade on its own.
The company is folding this trial together with two other tafenoquine studies into a single regulatory package, which will determine whether the agency treats the combined evidence as sufficient.

The result

60 Degrees Pharmaceuticals, Inc. (60 Degrees Pharmaceuticals LLC in the trial registry) said all three patients enrolled in NCT06478641, an open-label expanded-access study of its ARAKODA (tafenoquine) regimen combined with atovaquone, cleared babesiosis infection. The trial enrolled immunosuppressed adults with relapsing babesiosis who had already failed conventional antimicrobial regimens, a population with risk factors such as asplenia or immunosuppressive drug use that predispose to repeat relapse. No FDA-approved treatment or vaccine exists for babesiosis, and the study was designed specifically to confirm the high cure rate for tafenoquine that Yale researchers reported in a 2024 Clinical Infectious Diseases publication. 60+1

Probability of Success

Endpoint Met24%

Completes1%

Clinical Significance3%

Regulatory82%

How it was assessed

The protocol called for a follow-up visit 60 days after clinical resolution and cessation of study drug, at which two molecular tests checked for lingering parasite infection: a standard RT-PCR run by the Mayo Clinic, and a more sensitive RNA amplification test that the FDA has licensed for blood donation screening and that the company says is at least 100 times more sensitive than the Mayo assay. All three patients tested negative on both assays. The first patient to complete the regimen cleared infection on this basis, and the sponsor later confirmed the same result held across the full enrolled cohort of three. 60

The regulatory path

60 Degrees submitted a Breakthrough Therapy Designation request to the FDA on October 3, 2025, and said it planned to request a Type B meeting (a mid-development FDA discussion) in early 2026 to discuss requirements for a supplementary new drug application. The company has said it intends to submit an NDA in 2026 using data from one or more of three tafenoquine babesiosis trials it sponsors, including this one, NCT06207370, and NCT06656351. That plan makes this trial one leg of a three-study package rather than a standalone registrational study; the trial itself is not registrational on its own terms. 60+1

The competitive frame

No other sponsor's trial in babesiosis shares tafenoquine's target or mechanism class in the competitive field surfaced for this indication; the only other trial identified in the broader search, a Phase 2 study of a cell-based immune therapy in kidney transplantation, treats an unrelated condition and mechanism. 60 Degrees' own earlier Phase 2 tafenoquine trial in babesiosis, NCT06207370, is the nearest precedent for this regimen, though it does not qualify as a direct comparator under a shared-target standard because the target for tafenoquine is not classified in available data. With no approved treatment and no active rival mechanism in this indication, the field's shape is less about competition than about whether a small, uncontrolled cohort like this one accumulates into evidence the FDA will accept.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.