60 Degrees Pharmaceuticals announced that an independent Data Safety Monitoring Board has recommended continuing its Phase 2 B-Free chronic Babesiosis study after reviewing safety data from the first six patients through Day 30. The open-label trial is evaluating recovery from fatigue following treatment with the ARAKODA regimen of tafenoquine in patients with severe persistent fatigue and laboratory evidence of exposure to Babesia spp. The company plans to enroll up to 100 patients, with the primary endpoint being resolution of fatigue at Day 90 compared with baseline. Tafenoquine is already approved in the United States for malaria prophylaxis under the brand name ARAKODA. There is currently no FDA-approved treatment for babesiosis, a tick-borne disease with an annual incidence of at least 25,000 cases.
60 Degrees Pharmaceuticals, Inc. Common StockDSMB recommends continuing Phase 2 babesiosis study after safety review, advancing drug development for an unmet medical need.