60 Degrees Pharmaceuticals announced plans to submit a Minor Use Minor Species (MUMS) designation request to the FDA for tafenoquine as a treatment for acute canine babesiosis in 2025, potentially addressing a significant unmet veterinary medical need. The submission will be based on results from three clinical efficacy studies that evaluated ARAKODA® (tafenoquine) for canine babesiosis, along with existing safety and manufacturing data.
Clinical Evidence Supporting MUMS Application
The clinical efficacy studies involved both experimental Babesia infections and dogs diagnosed with naturally acquired Babesia infection in veterinary clinics. One study was company-sponsored and conducted at North Carolina State University. Collectively, the studies demonstrated that tafenoquine, administered as ARAKODA tablets, was well tolerated and appeared to facilitate recovery from acute infection.
The company will conduct a gap analysis of its existing data prior to the MUMS submission, utilizing existing canine safety data and chemistry manufacturing and controls (CMC) data for tafenoquine generated through the clinical development of ARAKODA for malaria.
Addressing an Unmet Veterinary Need
Canine babesiosis represents a significant veterinary health challenge, with several hundred to several thousand cases occurring annually in the United States. The disease is an emerging tick-borne illness carried by the same tick vector as Lyme Disease. Currently, no FDA-approved oral treatment for canine babesiosis exists, and available treatments carry significant toxicity risk or the propensity to generate drug resistance.
"Data from the canine babesiosis studies are impactful when viewed in the larger context of the ground-breaking human babesiosis research we are now sponsoring," said Chief Executive Officer Geoff Dow. "The positive findings of the canine babesiosis study are in line with our earlier findings that tafenoquine could be effective against babesiosis in humans."
About Tafenoquine and ARAKODA®
Tafenoquine was originally discovered by Walter Reed Army Institute of Research and was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both formulations were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in their respective countries as prescription-only malaria prevention drugs.
According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, approximately 16 days, offers the advantage of less frequent dosing for malaria prophylaxis. For malaria prevention, individuals are prescribed ARAKODA® as 2 x 100 mg tablets once daily for three days prior to travel, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
Safety Considerations
ARAKODA® carries important safety warnings, including contraindications for patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, breastfeeding women with G6PD-deficient infants, patients with psychotic disorders, and those with known hypersensitivity to tafenoquine. The drug requires G6PD testing before prescribing due to hemolytic anemia risk and carries warnings for methemoglobinemia, psychiatric effects, and hypersensitivity reactions.
The most common adverse reactions include headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Company Background
60 Degrees Pharmaceuticals, founded in 2010, specializes in developing and marketing new medicines for infectious disease treatment and prevention. The company achieved FDA approval of ARAKODA® for malaria prevention in 2018 and collaborates with research organizations in the U.S., Australia, and Singapore. The company is headquartered in Washington D.C., with a majority-owned subsidiary in Australia, and has received support from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc.
