60 Degrees Pharmaceuticals Announces Tafenoquine Babesiosis Trial in Infectious Diseases Journal

The U.S. medical scientific community is advocating for clinical studies to enhance the understanding of babesiosis, an emerging tick-borne disease. In response, 60 Degrees Pharmaceuticals, Inc., a company specializing in the development of new medicines for infectious diseases, has announced an upcoming clinical trial for the drug tafenoquine in treating babesiosis. This will be the first and only such study in the United States, with patient enrollment expected to start in the summer of 2024.

The Journal of Infectious Diseases has published a letter detailing the proposed trial protocol. The letter, authored by 60 Degrees Pharmaceuticals' CEO, Geoff Dow, PhD, outlines plans to investigate the safety and efficacy of a combination treatment involving tafenoquine, atovaquone, and azithromycin in hospitalized babesiosis patients. This initiative follows recent discussions in the Journal that called for more medical literature on treating babesiosis safely and effectively.

Dr. Dow emphasized the significant unmet medical need for improved treatment and prevention methods for babesiosis in North America, Europe, and Northeast Asia. He mentioned that a clinical protocol has been submitted to the Food and Drug Administration (FDA) after consulting with key opinion leaders in the field. The upcoming study aims to contribute meaningfully to the global understanding of this serious, emerging infectious disease.

The clinical trial will evaluate a triple combination therapy consisting of 800 milligrams of tafenoquine plus the standard care of atovaquone-azithromycin for at least 10 days, compared to a matching placebo and atovaquone-azithromycin in hospitalized patients. Tafenoquine, known commercially as ARAKODA®, is approved in the United States for malaria prophylaxis. Its safety has been evaluated in multiple randomized, double-blind, active comparator or placebo-controlled trials lasting up to six months. However, tafenoquine has not yet been proven effective for treating or preventing babesiosis and is not FDA-approved for this use.

Babesiosis is a potentially life-threatening disease, particularly in immunosuppressed patients, and is steadily emerging in the United States. The planned study will be a randomized, double-blind, placebo-controlled trial involving at least 24 patients. The main study endpoints will be the time to sustained clinical resolution of babesiosis symptoms and molecular cure as determined by an FDA-approved nucleic acid test. The trial will take place at three hospitals in the northeastern United States.

While the efficacy and safety of 8-aminoquinolines, a class of drugs including tafenoquine and primaquine, are established for malaria, several case studies suggest that tafenoquine is also being used for babesiosis in clinical practice in the U.S. It is estimated that there may be around 47,000 cases of babesiosis annually in the U.S., based on the observation of 476,000 Lyme disease infections and an estimated 10 percent coinfection rate with babesiosis.

Tafenoquine was discovered by the Walter Reed Army Institute of Research, and the current study is funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in the U.S. in 2018 under the name ARAKODA® and in Australia as KODATEF®. Both were launched commercially in 2019 and are available at retail pharmacies as prescription-only malaria prevention drugs.

The Centers for Disease Control and Prevention (CDC) notes that the long terminal half-life of tafenoquine, approximately 16 days, offers potential advantages in less-frequent dosing for malaria prophylaxis. However, ARAKODA® is not suitable for everyone, and patients and prescribers should review important safety information before use.