Following Jan 17 FDA meeting, 60 Degrees Pharma plans pivotal babesiosis study for tafenoquine

60 DEGREES PHARMACEUTICALS, INC.

FDA Type C meeting on Jan 17, 2024 led to mutual alignment on design of pivotal study for tafenoquine in hospitalized babesiosis.
FDA indicated proposed study could support approval if clinical endpoint used; company revising protocol accordingly.
Patient enrollment targeted to begin in summer 2024 at three northeastern U.S. hospitals.
Tafenoquine (ARAKODA) is FDA-approved for malaria prophylaxis but not yet for babesiosis; estimated 47,000 patients/year in U.S.

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