60 Degrees Pharmaceuticals Hits Enrollment Milestone in Babesiosis Trial; Interim Data Due October 2026 — 60 Degrees Pharmaceuticals, Inc.

Event summary

60 Degrees Pharmaceuticals has enrolled the minimum 24 patients required to trigger an interim analysis in its hospitalized babesiosis study.
Interim data readout is planned for October 6, 2026, with potential early trial termination if primary endpoint is met.
The study evaluates tafenoquine (ARAKODA®) plus standard of care versus placebo in severe babesiosis patients.
Key endpoints include time to sustained clinical recovery and molecular clearance of Babesia parasites.

The big picture

60 Degrees Pharmaceuticals is advancing its clinical trial for tafenoquine in severe babesiosis, a vector-borne disease with significant unmet medical need. The company's focus on repurposing an existing malaria prophylaxis drug highlights the strategic shift towards leveraging known compounds for new indications. Success in this trial could position 60 Degrees as a key player in the treatment of emerging infectious diseases.

What we're watching

Regulatory Pathway: Whether the FDA meeting following interim data will clarify requirements for a supplemental NDA submission.
Trial Outcomes: The potential for early trial termination if statistical significance is reached for the primary endpoint.
Market Opportunity: The strategic positioning of tafenoquine as a potential treatment for babesiosis, a disease with no FDA-approved therapies.