60 Degrees Pharmaceuticals Announces Clinical Improvement and Negative PCR Results in All Completed Expanded Access Babesiosis Study Patients
All five completed patients (100%) in 60P's expanded access babesiosis study reported much or very much improved outcomes with negative conventional PCR tests, and 80% were negative on a highly sensitive post-treatment NAT assay. Total enrollment is seven, with two patients still on treatment and the study open pending potential FDA discussions. The company plans to pursue accelerated approval using post-treatment NAT nonreactivity as a proposed surrogate endpoint. A separate randomized, placebo-controlled hospitalized-babesiosis study (NCT06207370) is expected to unblind in January 2027, followed by a pre-sNDA meeting request with FDA.
Key figures
- Drug Name
- tafenoquine (ARAKODA) in tafenoquine-atovaquone combination regimens
- Phase Of Trial
- Expanded access study (open-label, multi-site)
- Trial ids
- ["NCT06478641","NCT06207370"]
- Total enrollment
- 7
- Completed patients
- 5
- Nat sensitivity vs pcr
- 500-fold more sensitive
- Exploratory cox p value
- 0.019
- Hospital study unblinding
- January 2027
- Patients still on treatment
- 2
- Conventional pcr negative pct
- 100%
- Much or very much improved pct
- 100%
- Post treatment nat negative pct
- 80%
- Model expected rereatment free rate
- 23.5%
- Published case rereatment free rate
- 85.7%
AI analysis
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