60 Degrees Pharmaceuticals (SCTP) Study update summary

Hospital study

• DSMB review recommended completing planned enrollment of 33; 30 were enrolled by Oct. 1, 2026. No safety issues were identified, and the study remains blinded; the review did not assess efficacy.

• Enrollment will end at 30 to avoid a seasonal delay to unblinding, given the limited added statistical power expected from three more patients.

• Randomized, placebo-controlled trial compares tafenoquine plus atovaquone and azithromycin with placebo plus the same background therapy; primary endpoint is time to sustained clinical recovery, with molecular clearance a key secondary endpoint.

• Unblinding and endpoint results are expected in early 2027, with results targeted for January.

Expanded access and prior evidence

• Molecular cure by sensitive nucleic acid testing was confirmed in the first three expanded-access patients; outcomes or final screening data for two additional patients are expected in early November 2026.

• Earlier case-series evidence reported an 85% cure rate with tafenoquine plus standard antibiotic therapy; six of seven reported patients were successfully treated, with no relapse after initial treatment among those described.

• Published case reports suggest tafenoquine with atovaquone-containing regimens for at least eight weeks may benefit high-risk patients with treatment-refractory, relapsing babesiosis.

Regulatory plans and milestones

• A potential accelerated-approval filing could rely on literature and expanded-access cases, with a proposed confirmatory study; a positive hospital study could support a regular sNDA pathway.

• The proposed literature-based pathway would ask FDA to consider NAT-based molecular clearance as a surrogate endpoint; FDA will determine acceptability and data or post-marketing requirements.

• A pre-sNDA meeting request is planned for January 2027, with FDA discussions targeted for Q2 2027; expanded-access updates are expected in November and potential launch in Q1 2028, subject to FDA interactions and results.

• Tafenoquine is FDA-approved for malaria prevention as ARAKODA, but not to treat or prevent babesiosis.