• Further validates continuation of the B-FREE Study to evaluate the efficacy and safety of ARAKODA^® (tafenoquine) for treatment of chronic babesiosis
• Data support theory among specialists that Babesia infection may prolong recovery times in patients with chronic fatigue

WASHINGTON, Dec. 29, 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, today announced that infection with Babesia, a parasite that causes the emerging tick-borne illness called babesiosis, was found in 24 percent of a cohort of 50 patients with chronic fatigue in a study conducted by researchers at North Carolina State University, and published in Pathogens.

Results announced today contribute to efforts to confirm a long-held theory within the U.S. vector-borne disease community that Babesia and chronic disease may be linked – specifically, that Babesia infection may prolong recovery times in patients with chronic fatigue.

The results also reinforce the importance of the B-Free Chronic Babesiosis Study (NCT06656351), which is evaluating efficacy and safety of the ARAKODA regimen of tafenoquine over 90 days for resolution of severe fatigue in patients with chronic babesiosis. The Company’s B-Free Study is now enrolling at the Icahn School of Medicine at Mount Sinai in New York.

“Healthcare providers who treat tick-borne illness may not be surprised by the results of this study,” said 60 Degrees Pharma Chief Executive Officer, Geoffrey Dow. “While the results don’t prove that Babesia infection causes chronic disease, they are consistent with that hypothesis and highlight the need for prospective controlled studies which the Company is now undertaking.”

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.

About the North Carolina State University Chronic Fatigue Study

The study involved a cohort of 50 participants selected from a group of 173 individuals who self-reported a history of chronic diseases and potential exposure to arthropod vectors. Participants had all experienced fatigue for at least six months with concurrent neurological symptoms. Participants provided three blood samples over a week, which were archived and later cultured and tested for Babesia DNA using PCR assays.

The study was conducted under an Institutional Review Board (IRB)-approved protocol and was funded in part by 60 Degrees Pharma.

About Babesiosis

Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease. Insurance claims research commissioned by the Company suggest that the minimum annual incidence of babesiosis is at least 25,000 cases per year, although the true number may be much larger than this. Currently no U.S. Food and Drug Administration (FDA)-approved treatment exists specifically for babesiosis.

Babesia infection persists for months, and potentially for several years, following a tick bite. In patients with risk factors (e.g., immunosuppression, age, asplenia), persistent infection may result in recurring clinical relapses of the disease, each with the potential for hospitalization. In individuals without such known risk factors, it has been generally assumed that persistent infection is not clinically meaningful. However, the potential clinical significance of persistent infection in individuals with dysregulated immune systems (e.g., chronic tick-borne diseases, long Covid and other long syndromes) has not been studied, but is hypothesized to complicate recovery from other chronic symptoms. The lack of sufficiently sensitive, FDA-approved diagnostics has stymied efforts to study this problem.

About 60 Degrees Pharmaceuticals, Inc.

60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA^® (tafenoquine), for malaria prevention in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

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