60 Degrees Submits FDA MUMS Request for Tafenoquine in Canine Babesiosis Treatment

60 Degrees Pharmaceuticals plans to submit a request to the FDA for Tafenoquine in canine babesiosis treatment. The company specializes in developing and marketing new medicines for infectious diseases, with a focus on vector-borne diseases. Its lead product, ARAKODA, is an antimalarial for malaria prevention in adults.

Washington, July 2, 2025 — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW), a company focused on developing new medicines for infectious diseases, has announced plans to submit a Minor Use Minor Species (MUMS) designation request to the United States Food and Drug Administration (FDA) for tafenoquine, marketed as ARAKODA, to treat acute canine babesiosis. This submission is based on data from three clinical studies demonstrating tafenoquine's efficacy in treating the tick-borne illness in dogs.

The clinical studies evaluated ARAKODA's efficacy in experimental Babesia infections and naturally acquired Babesia infection in veterinary clinics. One of the studies was conducted at North Carolina State University. The findings indicated that tafenoquine, administered as ARAKODA tablets, was well-tolerated and appeared to facilitate recovery from acute infection [1].

Canine babesiosis is an emerging tick-borne illness carried by the same tick vector as Lyme disease. No FDA-approved oral treatment for canine babesiosis exists, and current treatments carry significant toxicity risks or the propensity to generate drug resistance. The submission to the FDA aims to address this gap in treatment options [1].

Tafenoquine, discovered by the Walter Reed Army Institute of Research, was approved for malaria prophylaxis in 2018 in the United States and Australia. It has a long terminal half-life of approximately 16 days, offering the advantage of less frequent dosing for malaria prophylaxis [1]. Although tafenoquine has not been proven effective for babesiosis treatment or prevention, the clinical data suggest its potential efficacy in this indication.

60 Degrees Pharmaceuticals, Inc. was founded in 2010 and specializes in developing and marketing new medicines for infectious diseases. The company achieved FDA approval for ARAKODA in 2018 for malaria prevention. The submission of the MUMS designation request aligns with the company's mission to expand the use of tafenoquine and develop new treatments for infectious diseases [1].

The submission process involves a gap analysis of existing data and will be based on the results of the clinical efficacy studies, existing canine safety data, and chemistry manufacturing and controls (CMC) data generated through the clinical development of ARAKODA for malaria. The company is also collaborating with prominent research organizations and has received support from the U.S. Department of Defense and private institutional investors [1].

References:

[1] https://finance.yahoo.com/news/60-degrees-pharmaceuticals-submit-mums-200100464.html