ARAKODA (tafenoquine)

July 29, 2026: 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP, SXTPW) announced it has enrolled the minimum 24 patients required to trigger an interim analysis in its double-blind, randomized, multisite, placebo-controlled trial of oral tafenoquine plus standard of care vs placebo plus standard of care for hospitalized patients with severe babesiosis (NCT06207370). The data safety and monitoring board will conduct the interim analysis, evaluating time to sustained clinical recovery (primary endpoint) and time to molecular clearance of Babesia parasites (key secondary endpoint). If the primary endpoint reaches statistical significance, the study will be halted early; the DSMB may also recommend enrolling more patients or closing the study if significance is not achieved or is unlikely with additional enrollment.

The company said the interim analysis outcome will be disclosed no later than October 6, 2026, while enrollment continues. After the interim readout, 60 Degrees plans to request an FDA meeting to discuss data requirements and a regulatory pathway toward a potential supplemental NDA for tafenoquine in babesiosis. Tafenoquine is currently FDA-approved for malaria prophylaxis (ARAKODA) but is not approved for babesiosis; the release notes there is no FDA-approved treatment or vaccine for babesiosis.