60 Degrees suspends Phase IIB tafenoquine COVID-19 study; pivots to malaria and babesiosis

60 DEGREES PHARMACEUTICALS, INC.

Company will not re-submit IND for Phase IIB study (ACLR8-LR) of tafenoquine in mild-to-moderate COVID-19 after FDA feedback made U.S. enrollment unfeasible.
Shifts focus to ARAKODA (tafenoquine) commercialization for malaria prophylaxis and preparation for Phase IIA study in hospitalized babesiosis patients.
ARAKODA sales increased 150% in Q2 2023 vs Q2 2022; plans to appoint chief commercial officer and submit pre-IND meeting request for babesiosis in Q4 2023.
FDA advice indicated placebo-controlled study allowed only when nirmatrelvir/ritonavir is not clinically appropriate, making patient recruitment very challenging.

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