60 Degrees Pharmaceuticals to Unblind Babesiosis Trial Early, Aims…

Event summary

60 Degrees Pharmaceuticals will conclude enrollment in its severe babesiosis trial at 30 patients, down from the planned 33, due to marginal statistical power gains and seasonal constraints.
Primary and secondary endpoint results are expected in January 2027, with no safety signals identified in the interim analysis.
The company will seek a pre-sNDA meeting with the FDA in January 2027 to discuss regulatory pathways for severe or treatment-refractory babesiosis.
Additional data from an expanded access study of tafenoquine in relapsing, treatment-refractory babesiosis will be disclosed in early November 2026.

The big picture

60 Degrees Pharmaceuticals is positioning tafenoquine as a potential treatment for severe babesiosis, a tick-borne disease with rising incidence and no FDA-approved therapies. The company's strategy hinges on leveraging existing case reports and expanded access data to secure regulatory approval, while the seasonal nature of babesiosis adds urgency to the timeline. The outcome of the pre-sNDA meeting with the FDA will be critical in determining the viability of this regulatory pathway.

What we're watching

Regulatory Pathway: Whether the FDA will accept molecular clearance as a surrogate endpoint for accelerated approval of tafenoquine in babesiosis.
Clinical Efficacy: The impact of the early trial unblinding on the statistical power and interpretability of the primary and secondary endpoints.
Market Opportunity: The pace at which 60 Degrees can expand the use of tafenoquine beyond malaria prevention into treatment-refractory babesiosis.