60 Degrees Pharmaceuticals has announced the Institutional Review Board (IRB) approval of an open-label, expanded access study evaluating the ARAKODA regimen of tafenoquine in combination with standard of care for immunosuppressed patients suffering from persistent or relapsing babesiosis. This initiative seeks to confirm promising findings from a Yale School of Public Health (YSPH) case series.
Tafenoquine's Potential in Babesiosis Treatment
The YSPH case series, published in Clinical Infectious Diseases, demonstrated an 80% cure rate (95% confidence interval: 30-100%) in five immunosuppressed patients treated with weekly tafenoquine following a loading dose, alongside standard medications. Tafenoquine is currently approved in the United States under the brand name ARAKODA for malaria prophylaxis. However, it is not yet FDA-approved for the treatment or prevention of babesiosis.
Addressing a Growing Threat
Babesiosis, a tick-borne illness caused by Babesia parasites, is increasingly prevalent, particularly in the Northeast. The disease, transmitted by the same black-legged tick that spreads Lyme disease, can cause symptoms such as fevers, chills, sweats, and fatigue. In severe cases, babesiosis can be life-threatening, especially for elderly and immunocompromised individuals.
Company's Perspective
"Tafenoquine is showing exciting promise in addressing babesiosis within various human patient populations," said Geoffrey Dow, PhD, Chief Executive Officer of 60 Degrees Pharmaceuticals. "With babesiosis rates now rising in key regions of the United States and given the very serious nature of this tick-borne illness, especially in the elderly and immunocompromised people, we are moving quickly in an effort to confirm Yale’s observations while advancing the clinical program for hospitalized babesiosis patients which is now enrolling at Tufts Medical Center. Ultimately, we aim to re-purpose tafenoquine as a new babesiosis treatment."
Comprehensive Clinical Program
60 Degrees Pharmaceuticals is actively engaged in multiple clinical trials to assess the safety and efficacy of tafenoquine in different patient populations:
- A study of hospitalized (acute) babesiosis patients, currently enrolling at Tufts Medical Center.
- An expanded access trial to validate recent findings by Yale School of Public Health.
- An expanded access study planned for chronic babesiosis, with the design informed by an ongoing epidemiological study at North Carolina State College of Veterinary Medicine.
These studies aim to address unmet medical needs in patients with severe disease, those at risk of relapse, and individuals diagnosed with chronic babesiosis based on clinical manifestations and medical history. The company anticipates filing a New Drug Application (NDA) with the FDA in the second quarter of 2026 for a supplemental indication for tafenoquine in babesiosis.
Market Potential
60 Degrees Pharmaceuticals estimates a substantial accessible market for ARAKODA (tafenoquine) for babesiosis, projecting 38,000 acute patients (hospitalized and immunosuppressed) and at least 375,000 patients with chronic babesiosis through the end of patent protection in December 2035. This is in addition to the potential 1.7 million travelers who could benefit from ARAKODA for malaria prophylaxis during the same period.
