60 Degrees Pharma Says Central Study Site For B-FREE Chronic Babesiosis Study Is Open For Patient Enrollment At Mount Sinai Icahn School Of Medicine

• 90-day trial will measure change in general fatigue in patients with chronic babesiosis following tafenoquine treatment
• Study will run approximately 12 months and enroll up to 100 patients
• Internal estimates of the unmet medical need are between 4,400 and 190,000 cases annually, with no existing FDA-approved treatment for babesiosis

WASHINGTON, Nov. 21, 2025 (GLOBE NEWSWIRE) -- 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 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 (NCT06656351) is a Phase 2 open-label study that will evaluate the efficacy (and safety) 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 (FDA) to date.

The unmet medical need from current claims data suggests approximately 4,400 diagnosable cases of chronic babesiosis with severe fatigue in the U.S. each year, while internal market research indicates the number could be as high as 190,000 if molecular testing confirms broader prevalence. One of the central aims of the B-FREE study is to establish whether Babesia infection in patients with a chronic babesiosis diagnosis can be confirmed using validated molecular tests, which will help determine the true size of the patient population. By clarifying whether the market size falls closer to the conservative estimate, or approaches the higher bound, the study is designed not only to advance clinical science but also to quantify the scope of unmet medical need.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the United States Food and Drug Administration for such an indication.