Clinical TrialOct 6, 2026, 07:56 AM
60 Degrees Pharmaceuticals Plans January 2027 Babesiosis Data Readout
AI Summary
60 Degrees Pharmaceuticals announced an update regarding its clinical trial for tafenoquine in patients hospitalized with severe babesiosis. The company will conclude enrollment at 30 patients, with results expected in January 2027. The DSMB recommended completing the study as planned, and no safety issues were identified. The company plans to request a pre-sNDA meeting with the FDA in January 2027 to discuss regulatory pathways, and additional data from a separate expanded access study will be released in November 2026.
Key Highlights
- 60 Degrees Pharmaceuticals to conclude enrollment in severe babesiosis study at 30 patients.
- Primary and secondary endpoint results for the severe babesiosis study are expected in January 2027.
- The Data Safety Monitoring Board (DSMB) recommended completing the study with the originally planned 33 patients but no safety signals were identified.
- The company will seek a pre-Supplemental New Drug Application (sNDA) meeting with the FDA in January 2027.
- Additional data from the expanded access study for treatment-refractory babesiosis will be disclosed in early November 2026.
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