First Patient Enrolled in Tafenoquine Babesiosis Trial at Tufts

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW), a company dedicated to developing medicines for infectious diseases, has announced the enrollment of the first patient in a clinical trial to investigate the use of tafenoquine for treating babesiosis. The trial, which is both randomized and double-blind, is set to be conducted at Tufts Medical Center in Boston, with plans to recruit between 24 and 33 participants. This marks the world's inaugural clinical study focused on evaluating tafenoquine as a treatment for human babesiosis.

Geoff Dow, PhD, CEO of 60 Degrees Pharmaceuticals, expressed optimism about this milestone, emphasizing the significance of developing a new treatment option for babesiosis. He noted the increasing prevalence of the disease, which is often challenging to distinguish from other illnesses in clinical settings. Dow highlighted the potential for tafenoquine to effectively and safely treat this serious tick-borne disease, which can be life-threatening, particularly for elderly and immunosuppressed patients.

Babesiosis is primarily transmitted through the bite of the black-legged tick, the same vector responsible for spreading Lyme disease. As an orphan disease, it poses a significant health risk to those who contract it, especially if they are elderly or immunocompromised.

60 Degrees Pharmaceuticals is in negotiations with other prominent university hospitals to join the study. Tafenoquine is already approved for malaria prophylaxis in the United States under the brand name ARAKODA®. Its safety profile has been established through multiple clinical trials, but it has not yet been proven effective for treating or preventing babesiosis and lacks approval from the U.S. Food and Drug Administration (FDA) for this use.

Recently, tafenoquine received orphan drug designation from the FDA for babesiosis treatment, a significant milestone that underscores its potential importance in addressing this unmet medical need.

The clinical trial will compare the safety and efficacy of tafenoquine against a placebo in patients hospitalized with acute babesiosis. The primary endpoints are the time to sustained clinical resolution of symptoms and molecular cure, as determined by an FDA-approved nucleic acid test (NAT). The recruitment goal is to enroll enough patients to allow a meaningful interim analysis, including a significance test and size re-estimation for potential additional recruitment. The study will be conducted across three hospitals in the northeastern United States, with the target enrollment period during the 2024 tick season, from June to September, if the caseload is sufficient.

Tafenoquine, branded as ARAKODA® in the United States, was discovered by the Walter Reed Army Institute of Research. Approved for malaria prophylaxis in 2018, it is marketed in the U.S. and Australia (under the name KODATEF®) and is available via pharmaceutical wholesalers to retail pharmacies. The drug's long terminal half-life, approximately 16 days, may offer advantages in dosing frequency for malaria prevention, according to the Centers for Disease Control and Prevention (CDC).

However, ARAKODA® is not suitable for everyone. Contraindications include patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, pregnant women, and those with a history of psychotic disorders. Common side effects include headaches, dizziness, and gastrointestinal issues, among others.

60 Degrees Pharmaceuticals, founded in 2010 and based in Washington D.C., focuses on developing treatments for infectious diseases. The company collaborates with research organizations in the U.S., Australia, and Singapore and has received support from the U.S. Department of Defense and private investors.