60 Degrees Pharmaceuticals, Inc., a pharmaceutical company focused on developing new medicines for infectious diseases, today announced the signing of a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.

Tafenoquine is not currently approved by the U.S. Food and Drug Administration (“FDA”) for the treatment and prevention of babesiosis.

The agreement follows initiation of collaboration between researchers from both organizations to study the activity of tafenoquine against babesiosis, a serious tick-borne disease caused by microscopic parasites that infect red blood cells.

“This agreement demonstrates the growing confidence 60 Degrees Pharmaceuticals, Yale School of Medicine, and Yale School of Public Health have in the potential that tafenoquine is now showing as a next-generation therapeutic for babesiosis,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Inc., Geoff Dow, PhD. “Today, a babesiosis patient who progresses past the initial stages of mild symptoms may have limited treatment options. If approved, tafenoquine has the potential to meet this growing unmet need. Tafenoquine also has the potential to become the first prophylaxis available for babesiosis.”

“Relapsing babesiosis occurs in highly immunocompromised patients, is very difficult to treat, and has an estimated mortality rate of 20 percent. There is a critical need to develop new antimicrobials for use in these patients,” said Peter James Krause, MD, Senior Research Scientist in Epidemiology (Microbial Diseases), in Medicine (Infectious Diseases) and in Pediatrics (Infectious Disease) and Lecturer in Epidemiology (Microbial Diseases) at Yale University.

About Babesiosis and the Study of Tafenoquine for Patients Hospitalized with Babesiosis
Babesiosis is a steadily emerging, infectious disease caused by a microscopic parasite, Babesia. It is transmitted through the bite of the black-legged (deer) tick, the vector that also spreads Lyme disease. Babesiosis, an orphan disease, may be life-threatening in elderly and immunosuppressed patients. Up to 10 percent of Lyme disease patients may be coinfected with Babesia. Therefore, up to 47,600 of the estimated 476,000 patients with new Lyme infections each year may be coinfected with Babesia. Cases reported in the medical literature suggest tafenoquine is a promising therapeutic for patients with relapsing babesiosis. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, are well documented.

60 Degrees Pharmaceuticals is the sponsor of a clinical trial (NCT06207370) evaluating the efficacy and safety of tafenoquine in treating severe babesiosis in humans. The trial is now enrolling and is being conducted at multiple sites in the U.S., including at Tufts Medical Center, Rhode Island Hospital, Yale University and Brigham and Women’s Hospital. The study is a randomized, double-blind, placebo-controlled trial that compares the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis and treated with standard-of-care. The two main study endpoints will be the time to sustained clinical resolution of symptoms and the time to molecular cure as determined by an FDA-approved nucleic acid test. At least 24, and as many as 33 patients, will be recruited before an interim analysis is conducted. The interim analysis will include both a test of significance, as well as size re-estimation to allow additional recruitment if required.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.