Tufts Medical Center to Begin Tafenoquine Babesiosis Trial, a First

Washington, May 30, 2024 – 60 Degrees Pharmaceuticals, Inc., a company specializing in treatments for infectious diseases, has announced a collaboration with Tufts Medical Center to initiate a pioneering clinical trial. This study will assess the safety and efficacy of tafenoquine, a drug currently approved for malaria prevention, in treating babesiosis, a serious tick-borne disease.

The clinical trial marks the world’s first official evaluation of tafenoquine for babesiosis treatment in humans. Recruitment for the trial will commence following a site initiation visit at Tufts Medical Center in Boston on June 13, 2024. The trial aims to enroll at least 24 patients diagnosed with babesiosis, a disease transmitted by the parasite Babesia through the bite of the black-legged tick. Babesiosis poses significant health risks, particularly to the elderly and immunocompromised individuals, and up to 10% of Lyme disease patients may be concurrently infected with Babesia.

Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, highlighted the urgency of this research: “With the rise in tick-borne illnesses in the U.S., babesiosis is becoming a major clinical concern. Literature indicates that tafenoquine could be a promising alternative for treating hospitalized patients with relapsing babesiosis. We are excited to partner with Tufts Medical Center for this groundbreaking trial.”

In addition to Tufts Medical Center, two other prominent university hospitals in the Northeast U.S. are expected to join the study, expanding the recruitment base. This region has seen a growing incidence of babesiosis, making it a critical area for research and treatment advancements.

The clinical trial will be a randomized, double-blind, placebo-controlled study, enrolling patients across several sites in the Northeast U.S. It will compare the safety and efficacy of tafenoquine against a placebo in hospitalized babesiosis patients. The primary endpoints will assess the time to sustained clinical resolution of symptoms and the time to molecular cure, as determined by an FDA-approved nucleic acid test (NAT). At least 24 patients, and potentially up to 33, will be recruited, with the possibility of additional recruitment based on interim analysis results. The study aims to complete enrollment during the 2024 tick season (June to September) if caseloads are high.

Tafenoquine, marketed under the name ARAKODA® in the U.S., is already approved for malaria prophylaxis. Its safety has been confirmed in multiple randomized, double-blind, controlled trials for durations up to six months; however, it has not yet been proven effective for babesiosis treatment. The study’s results could pave the way for an expanded indication for tafenoquine, addressing a significant public health need.

The 60 Degrees Pharmaceuticals mission, supported by both the U.S. Department of Defense and private investors, focuses on developing new treatments for infectious diseases. The company, founded in 2010, is headquartered in Washington, D.C., with a subsidiary in Australia. It collaborates with research organizations globally, including those in the U.S., Australia, and Singapore.

The upcoming clinical trial represents a significant step forward in addressing babesiosis, providing hope for improved treatment options for a growing number of patients affected by this debilitating disease.

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