60 Degrees Pharmaceuticals has entered a clinical study agreement with the Icahn School of Medicine at Mount Sinai in the US, choosing it as the site to conduct an open-label Phase II trial of Arakoda (tafenoquine) for the treatment of chronic babesiosis.
This disease, transmitted by ticks, occurs due to the Babesia parasites, which proliferate within red blood cells.
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The study will focus on those who have been experiencing severe fatigue for at least a period of six months, in addition to other symptoms, and have lab-confirmed babesiosis.
It aims to assess the safety and efficacy of the regimen over 90 days for those with a presumptive diagnosis of the condition.
The primary goal of the trial is to determine whether there is a resolution of fatigue by day 90, as measured against the baseline using a patient-reported outcome metric, specifically the multi-dimensional fatigue inventory general fatigue subscale.
In the study, the oral administration of tafenoquine (two 100mg tablets) will be carried out with food on the first four days, followed by weekly doses starting on day 11 and concluding on day 89.
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By GlobalDataThe latest study has received funding from the US Army Medical & Materiel Development Activity.
60 Degrees Pharmaceuticals CEO Geoff Dow said: “We are pleased to welcome the Icahn School of Medicine at Mount Sinai research team into the 60 Degrees Pharma tafenoquine for babesiosis clinical trial programme.
“They bring deep expertise and skill in researching tick-borne illnesses, along with a focus on supporting the development of novel therapies to meet the critical unmet needs of patients with chronic disease.”
In addition to the ongoing Phase II study, 60 Degrees is sponsoring three studies to investigate tafenoquine’s efficacy and safety in treating babesiosis in humans.
Results from at least one of these trials are expected in the first half of 2026. These findings will contribute to a new drug application (NDA) that the company plans to submit to the US Food and Drug Administration (FDA) for the treatment of babesiosis.
The discovery of tafenoquine can be attributed to the research conducted by the Walter Reed Army Institute of Research.
Tafenoquine was first approved for malaria prophylaxis in the US in 2018 under the name Arakoda and as Kodatef in Australia. The medication is commercially available in both countries.
