60 Degrees Pharmaceuticals Announces The Company Will Conduct A Gap Analysis Of Its Existing Data Prior To Submitting A Minor Use Minor Species Designation Request To The U.S. FDA For Tafenoquine For The Treatment Of Acute Canine Babesiosis

Author: Benzinga Newsdesk | July 14, 2025 04:03pm

• Data from three independent clinical studies demonstrate utility of tafenoquine to treat acute canine babesiosis

WASHINGTON, July 14, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP, SXTPW))) ("60 Degrees" or the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the Company will conduct a gap analysis of its existing data prior to submitting a Minor Use Minor Species (MUMS) designation request to the United States Food and Drug Administration (FDA) for tafenoquine for the treatment of acute canine babesiosis. The submission will be based on results of three clinical efficacy studies that evaluated ARAKODA® (tafenoquine) for canine babesiosis, and existing canine safety data and chemistry manufacturing and controls (CMC) data for tafenoquine generated through the clinical development of ARAKODA for malaria.

The clinical efficacy studies involved experimental Babesia infections and dogs diagnosed with naturally acquired Babesia infection in veterinary clinics. One of the studies was company-sponsored and conducted at North Carolina State University. Collectively, the studies showed that tafenoquine, administered as ARAKODA tablets, was well tolerated and appeared to facilitate recovery from acute infection.

Every year in the United States, several hundred to several thousand cases of canine babesiosis are seen. It 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 currently available treatments carry significant toxicity risk or the propensity to generate drug resistance.

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