60 Degrees Pharmaceuticals (NASDAQ:SXTP), a specialist in medicines for vector-borne diseases, announced Wednesday that all three patients enrolled in its expanded-use clinical trial for relapsing babesiosis were successfully cured.
The results, when combined with prior data from a 2024 Yale School of Public Health report, demonstrate a near 100% cure rate across seven patients treated with a combination regimen featuring tafenoquine.
The study focused on highly vulnerable, immunosuppressed patients who had previously failed standard antimicrobial therapies.
The treatment protocol involved a weekly dose of tafenoquine added to atovaquone-containing combinations, sustained until patients achieved two consecutive negative molecular tests.
Clinical resolution was confirmed using high-sensitivity RNA amplification tests alongside standard PCR assays to ensure the complete eradication of the Babesia microti parasite.
Currently, the FDA has not approved any specific drug for the treatment of babesiosis.
While tafenoquine is marketed in the U.S. as ARAKODA for malaria prophylaxis, its use in treating babesiosis remains investigational.
However, 60 Degrees Pharmaceuticals noted that these latest findings warrant a formal review of existing treatment guidelines for relapsing cases, which currently have a mortality rate as high as 10% in patients with severe complications.
The company is currently scaling its commercial infrastructure in anticipation of broader market access.
Recent initiatives include a partnership with GoodRx to expand patient savings on ARAKODA and a new travel-focused telehealth collaboration with Runway Health.
With an estimated U.S. addressable market of up to 380,000 patients annually, the company projects that babesiosis treatments could represent a $1.1 billion cumulative revenue opportunity through its patent expiration in 2035.