60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) has announced that it has received Investigational Review Board (IRB) approval for its Phase II clinical study evaluating the efficacy and safety of Tafenoquine (ARAKODA® regimen) for the treatment of chronic babesiosis. The study, identified as NCT06656351, is an open-label trial designed to assess the drug's impact over a 90-day period in patients with a presumptive diagnosis of chronic babesiosis who have experienced significant functional impairment for at least six months. Patient enrollment is slated to begin in Q3 2025.
Addressing an Unmet Need in Babesiosis Treatment
Babesiosis, a tick-borne illness caused by Babesia parasites, is characterized by symptoms including fevers, chills, sweats, and fatigue. In severe cases, particularly among elderly and immunosuppressed patients, the disease can be life-threatening. The incidence of babesiosis is rapidly increasing, especially in the Northeast United States, where it is transmitted through the bite of the black-legged (deer) tick, the same vector that spreads Lyme disease. Currently, there are no approved treatment options specifically for chronic babesiosis, highlighting a significant unmet medical need.
Tafenoquine: A Potential Solution
Tafenoquine, already approved by the FDA for malaria prophylaxis under the brand name ARAKODA®, is being investigated for its potential to treat chronic babesiosis. The drug's safety profile has been previously assessed in five randomized, double-blind, active comparator or placebo-controlled trials for malaria prophylaxis, with durations of up to six months. According to the Centers for Disease Control and Prevention, tafenoquine's long terminal half-life of approximately 16 days may offer advantages in less-frequent dosing.
Geoff Dow, PhD, Chief Executive Officer of 60 Degrees Pharmaceuticals, Inc., stated, "As babesiosis continues to emerge in new regions of the U.S., the need to address its impact safely and effectively is also growing. The chronic phase of babesiosis particularly may prove to be one of the most important areas of study due to the estimated large size of the patient population, the severity and duration of symptoms, and the absence of any approved treatment option available today."
Market Opportunity
The company estimates a total cumulative addressable market exceeding 400,000 patients through the end of U.S. patent protection in December 2035 for ARAKODA® (tafenoquine) for babesiosis.
Important Safety Information
ARAKODA® (tafenoquine) is contraindicated in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, breastfeeding women with G6PD-deficient infants, patients with a history of psychotic disorders, and those with known hypersensitivity to tafenoquine or other 8-aminoquinolines. Warnings and precautions include the risk of hemolytic anemia, methemoglobinemia, psychiatric effects, and hypersensitivity reactions. Common adverse reactions include headache, dizziness, back pain, diarrhea, nausea, and vomiting.
