ARAKODA (tafenoquine)

October 6, 2026: 60 Degrees Pharmaceuticals (NASDAQ: SXTP, SXTPW) said it will stop enrollment at 30 patients, versus the planned 33, in its double-blind, randomized, placebo-controlled severe babesiosis trial of tafenoquine plus standard of care versus placebo plus standard of care (NCT06207370) and proceed to unblinding. The DSMB’s October 1 interim analysis recommended completing enrollment to 33; as of that date 30 patients had been enrolled. The company said adding three more patients would provide limited statistical benefit and could delay unblinding until fall 2027 because of seasonality. Primary and secondary endpoint results are expected in January 2027. The DSMB identified no safety signals. The primary endpoint is time to sustained clinical resolution; a key secondary endpoint is time to molecular clearance of Babesia parasites.

Also for tafenoquine in relapsing, treatment-refractory babesiosis, the company said its expanded access study (NCT06478641) has confirmed molecular cure by NAT in the first three patients treated with tafenoquine plus atovaquone-containing regimens; final screening data from two additional patients are expected in early November 2026. The company plans to request a pre-sNDA FDA meeting in January 2027 to discuss data requirements and a potential regulatory pathway, including possible accelerated approval using NAT-based molecular clearance as a surrogate endpoint.