Tafenoquine is an anti-malarial drug that interferes with parasitic growth in the body. But could it be repurposed for use in another parasitic illness? That’s what pharmaceutical company 60 Degrees Pharmaceuticals, Inc. (“60 Degrees”) is trying to figure out. 60 Degrees has been evaluating ARAKODA (tafenoquine) as a potential treatment for acute babesiosis, a parasitic tick-borne illness. So far, tafenoquine performed well in animal models of babesiosis. Because of this, 60 Degrees partnered with Tufts Medical Center to launch a first-in-human study of tafenoquine for humans with acute babesiosis.

This study seeks to understand how safe and effective this therapy is in this patient population. Trial recruitment opens on June 13, 2024. Hospitalized individuals with babesiosis who are at low risk of relapse will receive either tafenoquine or a placebo (alongside the standard-of-care antimicrobial treatment given for babesiosis). Study endpoints include how long it takes for symptoms to be resolved in the clinical and how long it takes for the participant to be cured based on a specific test.

According to a news release in Yahoo! Finance, the U.S. Food and Drug Administration (FDA) also sees tafenoquine’s promise in this sphere. As such, the FDA granted tafenoquine Orphan Drug designation. Orphan Drug designation is granted to drugs or biologics intended to diagnose, treat, or prevent rare conditions, or conditions affecting fewer than 200,000 people nationwide. This designation comes with benefits such as fee waivers and tax credits, increased regulatory assistance, and seven years of market exclusivity upon drug approval.

Babesiosis: The Basics

Ixodes scapularis, or deer ticks, become infected with Babesia (a microscopic parasite). When these deer ticks bite humans and transmit the infection, it causes babesiosis, a rare, malaria-like disease. The Babesia then infect red blood cells. Some research suggests that Lyme disease and babesiosis often exist as coinfections, with up to 10% of people with Lyme disease also having babesiosis. Transmission is most common during warmer months in the Northeast and upper Midwest areas of the United States. Babesiosis is variable in nature. Some individuals have no symptoms at all; others experience severe and life-threatening symptoms. If you are older in age, have no spleen, or are immune compromised, your chance of having a severe infection increases.

If you do have symptoms of babesiosis, these may include:

• High fever and chills
• Fatigue
• Excessive sweating
• Muscle and/or joint pain
• Headache
• Appetite loss
• Cough

Symptoms and complications of severe babesiosis include:

• Jaundice (yellowing of the skin, eyes, and mucous membranes)
• Dark urine
• Neck stiffness
• Abdominal pain
• An enlarged liver or spleen
• Shortness of breath
• Nausea and vomiting
• Sudden mood changes
• Hemolytic anemia

Doctors may treat babesiosis with antiprotozoals, antimalarials, and antibiotics, as well as blood transfusion in severe cases.