60 Degrees Pharma's B-Free Babesiosis Trial Clears Initial Safety Review, Advances After DSMB Recommendation
60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP, SXTPW))) ("60 Degrees Pharma" or the "Company"), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today that the independent Data Safety Monitoring Board has recommended continuation of the B-Free chronic babesiosis study ( NCT06656351 ), following a review of safety data from the first six patients from baseline through Day 30. The B-Free study is evaluating recovery from fatigue following treatment with the ARAKODA® regimen of tafenoquine (loading dose of 200 mg per day for four days, then 200 mg weekly through Day 90) in patients with severe persistent fatigue and laboratory evidence of exposure to Babesia spp. No FDA-approved treatment or vaccine exists for babesiosis. Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis. Tafenoquine is ap...
60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP, SXTPW))) ("60 Degrees Pharma" or the "Company"), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today that the independent Data Safety Monitoring Board has recommended continuation of the B-Free chronic babesiosis study ( NCT06656351 ), following a review of safety data from the first six patients from baseline through Day 30.
The B-Free study is evaluating recovery from fatigue following treatment with the ARAKODA® regimen of tafenoquine (loading dose of 200 mg per day for four days, then 200 mg weekly through Day 90) in patients with severe persistent fatigue and laboratory evidence of exposure to Babesia spp.
No FDA-approved treatment or vaccine exists for babesiosis.
Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis.
Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA® ( tafenoquine ).