US-based pharmaceutical company 60 Degrees Pharmaceuticals has received approval from the investigational review board (IRB) for a Phase II trial of Arakoda (tafenoquine) for treating chronic babesiosis.
The study will focus on the regimen’s safety and efficacy over 90 days for treating individuals with a presumptive diagnosis of the disease, who have suffered significant functional impairment for a minimum of six months.
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Subject enrolment for the trial is expected to begin in the third quarter of this year, with the US Army Medical & Materiel Development Activity to provide funding for the study.
Tafenoquine is currently approved in the US for malaria prophylaxis under the name Arakoda.
The Walter Reed Army Institute of Research discovered the therapy, whose safety profile has been established through five double-blind, randomised, active comparator or placebo-controlled studies for up to six months.
Tafenoquine has not yet proven effective for treating or preventing babesiosis and is not approved by the US Food and Drug Administration (FDA) for that indication.
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By GlobalDataThe Centers for Disease Control and Prevention has noted that the therapy’s long terminal half-life of around 16 days could offer benefits such as less frequent dosing for malaria prophylaxis.
Babesiosis is a tick-borne illness caused by babesia parasites that can be life-threatening, particularly for elderly and immunocompromised individuals.
60 Degrees Pharmaceuticals CEO Geoff Dow said: “As babesiosis continues to emerge in new regions of the US, the need to address its impact safely and effectively is also growing.
“The chronic phase of babesiosis particularly may prove to be one of the most important areas of study due to the estimated large size of the patient population, the severity and duration of symptoms, and the absence of any approved treatment option available today.”
Last year, 60 Degrees Pharmaceuticals signed agreements with three clinical trial sites to conduct the study of tafenoquine for babesiosis.
