60 Degrees Pharmaceuticals (SXTP) announced that the central study site for the Company’s B-FREE Chronic Babesiosis Study, the Cohen Center for Recovery from Complex Chronic Diseases at Mount Sinai Icahn School of Medicine, is open for patient enrollment. The study is the first to evaluate a therapeutic for chronic babesiosis and will run for approximately 12 months. The B-FREE Chronic Babesiosis Study is a Phase 2 open-label study that will evaluate the efficacy of the ARAKODA regimen of tafenoquine over 90 days for resolution of severe fatigue, and parasite eradication in patients diagnosed with chronic babesiosis. For the purposes of the study, chronic babesiosis is defined as a condition affecting a patient who has experienced disabling fatigue for at least six months, with other symptoms of babesiosis, and laboratory confirmation of exposure to Babesia parasites in the prior 12 months. No treatment for babesiosis has been approved by the U.S. Food and Drug Administration to date.
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