other material
confidence high
sentiment neutral
materiality 0.45
60 Degrees files SAP for tafenoquine babesiosis trial; interim analysis criteria set
60 DEGREES PHARMACEUTICALS, INC.
- 23 of 33 planned patients enrolled in randomized, placebo-controlled trial of tafenoquine for severe babesiosis (NCT0627370).
- Interim analysis at earlier of 10/30/26 or after 24 patients randomized and followed ≥50 days.
- Conditional power ≥80% for TTSCR with p≤0.02137 triggers early reporting; 50-80% triggers sample size reassessment (capped at 66 total).
- Company intends to apply for a National Priority Review Voucher if results support sNDA submission before Q1 2028.
- Sponsor and investigators remain blinded to interim analysis results if study continues.