60 Degrees Pharmaceuticals names chronic babesiosis trial B-FREE

60 Degrees Pharmaceuticals Inc. (NASDAQ: SXTP; SXTPW) announced the name of its chronic babesiosis clinical trial following a patient naming competition conducted through social media channels.

The Phase 2 study will be called the B-FREE Chronic Babesiosis Study and is scheduled to commence in early November, running for approximately 12 months. The trial will evaluate the efficacy and safety of tafenoquine over 90 days for resolution of severe fatigue and parasite eradication in patients with chronic babesiosis.

The company engaged patients diagnosed with chronic babesiosis nationwide through social media to submit potential study names. As recognition for the winning submission, 60 Degrees Pharmaceuticals donated $5,000 split between the International Lyme and Associated Diseases Education Foundation and Global Lyme Alliance.

The B-FREE study represents what the company describes as the first clinical trial to evaluate a potential therapeutic for chronic babesiosis. The open-label study will treat up to 100 patients with tafenoquine administered orally over a 12-week treatment period, with the primary endpoint being resolution of fatigue at Day 90 compared to baseline.

Chronic babesiosis is a condition where persistent Babesia infection may affect patients with compromised immune systems. Babesiosis is transmitted through black-legged tick bites, the same vector that spreads Lyme disease. Currently, no FDA-approved treatment exists specifically for babesiosis.

Tafenoquine is approved for malaria prophylaxis in the United States under the brand name ARAKODA but has not been proven effective for babesiosis treatment or prevention and lacks FDA approval for such indication.

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