60 Degrees Pharmaceuticals Selects Icahn School of Medicine at Mount Sinai as Central Clinical Trial Site for Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis

Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has initiated a Phase II clinical trial for tafenoquine (ARAKODA®) to treat chronic babesiosis, collaborating with the Icahn School of Medicine at Mount Sinai [1][5]. Company Overview - 60 Degrees Pharmaceuticals specializes in developing new medicines for vector-borne diseases and received FDA approval for ARAKODA® for malaria prevention in 2018 [21]. - The company is headquartered in Washington, D.C., and has a subsidiary in Australia, focusing on novel therapies for unmet medical needs [21]. Clinical Trial Details - The Phase II open-label study (NCT06656351) will assess the efficacy and safety of tafenoquine over a 90-day period in patients with chronic babesiosis, defined by disabling fatigue lasting at least six months [2][3]. - The primary endpoint is the resolution of fatigue, measured at Day 90 using a patient-reported outcome measure [3]. - Enrollment for the trial is expected to begin in Q4 2025, with completion anticipated by Q2 2026 [9]. Background on Babesiosis - Babesiosis is a tick-borne illness caused by Babesia parasites, leading to symptoms such as fever, chills, and debilitating fatigue, particularly affecting the elderly and immunosuppressed [6]. - The incidence of babesiosis is rising, especially in the Northeast United States, and there are currently no FDA-approved treatments for chronic babesiosis [6][9]. Tafenoquine (ARAKODA®) Information - Tafenoquine is currently approved for malaria prophylaxis but has not been proven effective for treating babesiosis [4][7]. - The drug was discovered by the Walter Reed Army Institute of Research and was approved in the U.S. in 2018, with commercial availability starting in 2019 [8].