60 Degrees Reports 100% Cure in Relapsing Babesiosis Trial, Calls Guideline Review
60 Degrees Pharmaceuticals reported that three immunosuppressed relapsing babesiosis patients achieved cure following a tafenoquine plus atovaquone regimen in its expanded-access trial (NCT06478641). Combined with Yale’s earlier four-patient study, seven evaluable cases exhibited 100% sustained negative PCR results, driving 60 Degrees to call for updated babesiosis treatment guidelines.
1. Expanded-Access Trial Results
In its open-label, multi-site expanded-access trial (NCT06478641), 60 Degrees enrolled three immunosuppressed patients with relapsing babesiosis who had failed conventional antimicrobials. All three achieved cure, defined by two consecutive negative PCR tests and non-reactive RNA amplification, after completing a tafenoquine plus atovaquone-based regimen sustained until molecular remission.
2. Combined Data With Yale Study
When combined with the Yale School of Public Health’s four-patient report, all seven evaluable cases demonstrated 100% sustained negative PCR results. This includes one patient who required a quadruple drug combination featuring atovaquone, azithromycin, proguanil and weekly tafenoquine to achieve non-reactive RNA amplification.
3. Call for Guideline Revision
Given the rarity of relapsing babesiosis in immunosuppressed patients and the high cure rate observed, 60 Degrees is urging a review of existing babesiosis treatment guidelines. Tafenoquine is currently approved only for malaria prophylaxis under the ARAKODA® brand and lacks FDA approval for babesiosis, prompting the company to highlight the need for updated recommendations.