Study Links Tick-Borne Parasite to Chronic Fatigue in 24% of Patients

WASHINGTON – December 29, 2025 – In a finding that could have significant implications for individuals suffering from long-term debilitating fatigue, a new study has detected infection from a tick-borne parasite in nearly a quarter of patients presenting with chronic fatigue symptoms. The peer-reviewed study, sponsored by 60 Degrees Pharmaceuticals and conducted by researchers at North Carolina State University, adds a crucial piece of evidence to a long-held theory among infectious disease specialists: that the parasite Babesia may be a hidden culprit in prolonging or complicating chronic illness.

Published in the journal Pathogens, the research discovered that 24 percent of a 50-patient cohort, all of whom had experienced persistent fatigue for at least six months, were infected with Babesia. This parasite is the causative agent of babesiosis, an emerging and increasingly common tick-borne illness. The announcement, made by 60 Degrees Pharmaceuticals (NASDAQ: SXTP), highlights the potential connection between persistent, difficult-to-diagnose symptoms and this often-overlooked infection, paving the way for more focused clinical investigations.

A Growing Concern: The Babesia-Fatigue Connection

The North Carolina State University study was designed to investigate a potential underlying cause for persistent, medically unexplained symptoms. Researchers selected 50 participants from a larger group of 173 individuals who self-reported chronic illnesses and potential exposure to ticks or other arthropod vectors. A key criterion for inclusion was experiencing fatigue for a minimum of six months, coupled with concurrent neurological symptoms.

To ensure rigorous testing, participants provided three separate blood samples over the course of a week. These samples were then cultured and subjected to highly sensitive polymerase chain reaction (PCR) assays to detect the presence of Babesia DNA. The finding that 24% of this symptomatic group tested positive for the parasite provides compelling, albeit preliminary, data supporting the hypothesis that Babesia infection may play a role in chronic disease states.

"Healthcare providers who treat tick-borne illness may not be surprised by the results of this study," said Geoffrey Dow, Chief Executive Officer of 60 Degrees Pharma, in a statement. He emphasized a cautious interpretation of the data, adding, "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."

Pivoting a Malaria Drug for a New Fight

The study's results provide a strong rationale for 60 Degrees Pharma's ongoing clinical trial, known as the B-FREE Chronic Babesiosis Study (NCT06656351). This trial aims to address the debilitating fatigue associated with the infection by evaluating the efficacy and safety of ARAKODA®, the company's brand of tafenoquine. While ARAKODA® received U.S. Food and Drug Administration (FDA) approval in 2018 for the prevention of malaria, its use for babesiosis remains investigational and it is not currently approved for this indication.

The B-FREE study is designed as a 90-day trial to determine if a regimen of tafenoquine can lead to the resolution of severe fatigue in patients diagnosed with chronic babesiosis. This represents a classic drug repositioning strategy, where a medication approved for one disease is tested for its potential to treat another, often one with few or no existing therapeutic options. Enrollment for the pivotal study is currently underway at the prestigious Icahn School of Medicine at Mount Sinai in New York, a sign of the medical community's interest in finding solutions for this condition.

Tafenoquine has not been proven to be effective for the treatment or prevention of babesiosis. The B-FREE study is the critical next step required to gather the robust clinical data needed to determine if it could one day become a therapeutic option for patients.

The Hidden Epidemic of Babesiosis

Babesiosis is a disease on the rise, particularly in the American Northeast, yet it remains relatively unknown to the general public compared to its notorious cousin, Lyme disease. Both illnesses are transmitted by the bite of the same vector: the black-legged tick, commonly known as the deer tick. Babesiosis is caused by microscopic parasites that invade and multiply within a person's red blood cells.

Acute symptoms often mimic a severe flu, including high fevers, drenching sweats, chills, and profound fatigue. For the elderly, those without a spleen, or individuals with compromised immune systems, the disease can escalate into a life-threatening condition. However, a growing area of concern is the long-term persistence of the parasite. Following a tick bite, the Babesia infection can linger for months or even years.

In individuals without major risk factors, it has often been assumed that this persistent, low-level infection is not clinically significant. However, the new study challenges that assumption, lending weight to the theory that for people with dysregulated immune systems—such as those with other chronic tick-borne diseases or conditions like long Covid—a persistent Babesia infection could significantly complicate recovery and perpetuate symptoms like fatigue. This effort has been hampered by the lack of sufficiently sensitive, FDA-approved diagnostic tools, which may lead to significant underdiagnosis. The company's commissioned insurance claims research suggests a minimum of 25,000 cases annually, but the true number is believed to be much larger. Currently, no FDA-approved treatment exists specifically for babesiosis, making it an orphan disease with a major unmet medical need.