60 Degrees Pharmaceuticals presents tafenoquine development update for babesiosis
SXTP•60 Degrees Pharmaceuticals is targeting a 2027 supplemental new drug application for tafenoquine in babesiosis, seeking national-priority review. A randomized hospital study enrolled 30 patients, while expanded-access treatment showed confirmed molecular clearance in its first three patients.
1. Development timeline
60 Degrees Pharmaceuticals is targeting a potential supplemental new drug application for tafenoquine in babesiosis in 2027 and is seeking national-priority review. Blinded follow-up in a randomized hospital study of 30 patients ends in early January 2027, with unblinding to follow.
2. Treatment results
Expanded-access treatment achieved confirmed post-treatment molecular clearance in the first three patients. Published cases showed responses in six of seven patients who received tafenoquine for at least eight weeks with concomitant atovaquone.
3. Recruitment remains slow
Recruitment for the chronic study remains slow; none of nine screened patients tested positive for B. microti by nucleic acid testing.
