Core Insights - 60 Degrees Pharmaceuticals is conducting a gap analysis of existing data to submit a Minor Use Minor Species (MUMS) designation request to the FDA for tafenoquine to treat acute canine babesiosis [1] - Tafenoquine, marketed as ARAKODA, has shown positive results in three clinical efficacy studies for treating canine babesiosis, indicating it is well tolerated and may facilitate recovery from acute infection [2][4] - Canine babesiosis is an emerging tick-borne illness with no FDA-approved oral treatment currently available, highlighting a significant market opportunity for tafenoquine [3] Company Overview - 60 Degrees Pharmaceuticals focuses on developing new medicines for infectious diseases and achieved FDA approval for ARAKODA for malaria prophylaxis in 2018 [16] - Tafenoquine was discovered by the Walter Reed Army Institute of Research and has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [4][16] - The company collaborates with prominent research organizations and has received support from the U.S. Department of Defense and private investors [16] Clinical Studies - The clinical efficacy studies involved both experimental and naturally acquired Babesia infections in dogs, with one study conducted at North Carolina State University [2] - The studies collectively demonstrated the potential of tafenoquine in treating canine babesiosis, aligning with earlier findings of its effectiveness against babesiosis in humans [4] Market Context - Canine babesiosis cases in the U.S. range from several hundred to several thousand annually, indicating a growing need for effective treatments [3] - Current treatments for canine babesiosis carry significant toxicity risks and the potential for drug resistance, creating a gap in the market that tafenoquine could fill [3]