60 Degrees to end babesiosis trial enrollment at 30 patients, unblinding in January 2027
60 Degrees Pharmaceuticals said it will stop enrolling its randomized hospital study of tafenoquine for severe babesiosis at 30 patients, three fewer than the 33 the data safety monitoring board (DSMB) recommended completing. The company cited limited statistical benefit from three more patients and the seasonal nature of the disease, which would delay unblinding to fall 2027. The DSMB's interim review identified no safety issues, but the filing states it did not establish whether the study met its endpoints.
Key points
- As of October 1, 2026, 30 patients were enrolled against a planned 33
- Primary and secondary endpoint results are expected in January 2027
- The company will request a pre-sNDA meeting with the FDA in January 2027
- Additional data from a separate expanded access study are expected in early November 2026
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 06, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.