Clinical TrialJul 29, 2026, 04:04 PM
60 Degrees Pharma Reaches Babesiosis Trial Interim Analysis Milestone
AI Summary
60 Degrees Pharmaceuticals, Inc. has enrolled the minimum 24 patients required to trigger an interim analysis in its clinical study (NCT06207370) evaluating tafenoquine for severe babesiosis. The outcome of this analysis, which assesses the drug's efficacy and safety, is expected to be disclosed by October 6, 2026. Following the interim readout, the company intends to meet with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for a New Drug Application (NDA) for tafenoquine in babesiosis, an indication for which there is currently no FDA-approved treatment.
Key Highlights
- Enrolled minimum 24 patients for interim analysis in severe babesiosis clinical study (NCT06207370).
- Interim analysis outcome to be disclosed no later than October 6, 2026.
- Study evaluates tafenoquine's efficacy and safety for severe babesiosis.
- Company plans FDA meeting post-analysis to discuss NDA pathway for tafenoquine in babesiosis.
- Tafenoquine (ARAKODA®) is currently approved for malaria prophylaxis in the US and Australia.
- No FDA-approved treatment or vaccine currently exists for babesiosis.
Price Impact
More from SXTP