Core Viewpoint - 60 Degrees Pharmaceuticals has signed a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to develop and commercialize tafenoquine for treating and preventing babesiosis, a tick-borne disease [1][2][3] Company Overview - 60 Degrees Pharmaceuticals, Inc. specializes in developing new medicines for infectious diseases and achieved FDA approval for its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018 [18] - The company collaborates with prominent research organizations in the U.S., Australia, and Singapore, and is headquartered in Washington D.C. [18] Tafenoquine Development - Tafenoquine is currently not approved by the FDA for babesiosis treatment or prevention, but the agreement with Yale aims to advance its development [2][6] - The drug has shown promise as a next-generation therapeutic for babesiosis, which has limited treatment options for patients with advanced symptoms [3][4] - The clinical trial (NCT06207370) sponsored by 60 Degrees is evaluating tafenoquine's efficacy and safety in treating severe babesiosis, with enrollment ongoing at multiple U.S. sites [5] Babesiosis Context - Babesiosis is caused by the Babesia parasite and transmitted by black-legged ticks, with a significant risk for elderly and immunocompromised patients [4] - An estimated 10% of Lyme disease patients may be coinfected with Babesia, indicating a substantial patient population that could benefit from tafenoquine if approved [4] Clinical Trial Details - The clinical trial is randomized, double-blind, and placebo-controlled, focusing on the time to sustained clinical resolution and molecular cure as primary endpoints [5] - The trial aims to recruit between 24 to 33 patients before conducting an interim analysis [5]
Sixty Degrees Pharmaceuticals Announces Patent License Agreement to Advance Development of Tafenoquine for Babesiosis Treatment and Prevention with Yale School of Medicine and Yale School of Public Health