Clinical TrialJul 9, 2026, 04:13 PM
60 Degrees Pharma Details Tafenoquine Babesiosis Trial Interim Analysis Plan
AI Summary
60 Degrees Pharmaceuticals has prepared a statistical analysis plan (SAP) for the interim analysis of its randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis (NCT0627370). The interim analysis will occur by October 30, 2026, or after 24 of the 33 planned patients have been randomized and followed for at least 50 days. The company has currently enrolled 23 patients and aims to apply for a Commissioner’s National Priority Review Voucher if the trial results support a supplementary New Drug Application (sNDA) submission to the FDA before the end of the first quarter of 2028.
Key Highlights
- Interim analysis for tafenoquine trial (NCT0627370) in severe babesiosis planned.
- Analysis by October 30, 2026, or after 24 of 33 planned patients are randomized and followed for 50+ days.
- Conditional power (CP) analysis for time to sustained clinical resolution (TTSCR) and time to molecular cure (TTMC).
- Early reporting if CP is at least 80% and one-sided statistical significance is 0.02137 or less for TTSCR.
- Sample size reassessment if CP is 50-80%, with an increase capped at 33 additional patients (66 total).
- Currently, 23 patients have been enrolled in the study.
- Company intends to apply for a Commissioner’s National Priority Review Voucher if results support sNDA submission by Q1 2028.
Price Impact
More from SXTP