60 Degrees Pharmaceuticals, Inc. filed a Current Report on Form 8-K on October 6, 2026, to disclose updates regarding its clinical development of tafenoquine for the treatment of severe babesiosis. The company updated its investor presentation, which is furnished as Exhibit 99.1 to the filing, and attached a press release as Exhibit 99.2.
The updated investor presentation outlines a clinical development plan focused on severe and relapsing babesiosis. The presentation highlights a randomized, placebo-controlled study involving hospitalized babesiosis patients, which is evaluating tafenoquine plus standard of care versus placebo plus standard of care. The primary endpoint of this study is Time to Sustained Clinical Resolution (TTSCR).
As of October 1, 2026, the company reported that 30 patients have been enrolled in the hospital study. The presentation details an interim analysis scenario and feedback from an independent Data Safety Monitoring Board (DSMB). The DSMB reviewed the data and recommended that the company complete the study as originally planned and enroll the originally intended 33 subjects. The board found no safety signal preventing the use of tafenoquine in severe babesiosis. The company has suspended further enrollment of the final three subjects to avoid delaying the data readout until the following tick season.
The filing indicates that follow-up for the current 30-patient dataset will complete in early January 2027, followed by unblinding of the data. The presentation outlines two potential regulatory pathways for a supplemental New Drug Application (sNDA) based on the hospital study outcome. If the randomized study is positive, the company may pursue a regular sNDA. If the study is not independently pivotal, the company may seek accelerated approval using refractory-disease evidence and a potential surrogate marker of parasite clearance.
The company also discussed an expanded-access study for relapsing immunosuppressed patients, noting that six patients have been enrolled. The presentation lists anticipated milestones, including a pre-sNDA meeting with the FDA in the first quarter of 2027 and a potential filing in the second quarter of 2027.
