60 Degrees Pharmaceuticals Gains DSMB Clearance to Continue Tafenoquine Phase 2 Study in Chronic Babesiosis

With no FDA-approved treatment for babesiosis on the market, 60 Degrees Pharmaceuticals has cleared a meaningful early hurdle: the independent Data Safety Monitoring Board has recommended continuation of the B-FREE Phase 2 study following a safety review of the first six enrolled patients through Day 30. The decision keeps the ARAKODA® (tafenoquine) program on track in an indication where regulatory precedent is effectively absent.

The B-FREE study (NCT06656351) is an open-label trial evaluating the ARAKODA regimen, 200 mg daily for four days, then 200 mg weekly through Day 90, in patients presenting with severe persistent fatigue and laboratory-confirmed exposure to Babesia spp. The primary endpoint is resolution of fatigue at Day 90, measured via the multidimensional fatigue inventory general fatigue subscale, a patient-reported outcome instrument. Enrollment targets up to 100 patients, with a minimum efficacy-evaluable cohort of 16 patients confirmed by validated molecular testing at baseline.

For regulatory affairs leads, the diagnostic framework embedded in the protocol carries particular weight. Participants are screened using an FDA-licensed RNA amplification test alongside two CLIA-validated RT-PCR assays, a layered approach that reflects the absence of a cleared diagnostic standard for chronic babesiosis and will likely inform any future NDA or BLA submission strategy. The company's use of validated molecular confirmation at baseline also signals awareness of the evidentiary bar the agency will apply to an orphan indication with no prior approval history.

Babesiosis is transmitted by the black-legged tick and causes parasitic infection of red blood cells; incidence is rising in the Northeast, with company-commissioned insurance claims data suggesting a minimum of 25,000 cases annually. Persistent infection lasting months to years is documented, with recurring clinical relapses in immunosuppressed, elderly, and asplenic patients. The potential burden in populations with dysregulated immune systems, including those with long COVID or other post-infectious syndromes, has not been formally quantified, but the company hypothesises it substantially exceeds acute case counts.

Tafenoquine holds existing 21 CFR-compliant manufacturing and safety data from its approved malaria prophylaxis indication, which may reduce some CMC burden for a supplemental or new indication filing, though a full process validation package for the babesiosis population would still be required. Manufacturing scale-up planning should account for the 12-week oral self-administration regimen and the relatively small but growing orphan patient population.

The next scheduled data review point will be the Day 90 primary endpoint readout, which will determine whether the fatigue resolution signal is sufficient to support advancement toward a pivotal study or regulatory submission.

Source: 60 Degrees Pharmaceuticals via GlobeNewswire, July 1, 2026.