FOR IMMEDIATE RELEASE - The JPM CBRN Medical executed an agreement with 60P to study the effectiveness of an existing drug that shows promise against COVID-19.
FORT DETRICK, Md. – February 22, 2021 – The Department of Defense (DOD) awarded a $5 million agreement to 60 Degrees Pharmaceuticals, LLC. (60P), to initiate a Phase II clinical trial to evaluate the clinical benefit of tafenoquine for treatment of mild to moderate COVID-19 disease.
This award builds on previous DOD investments that developed tafenoquine as an oral treatment for the prevention of malaria. Evidence suggests that tafenoquine may also inhibit SARS-CoV-2 replication. Because tafenoquine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of malaria, its safety profile and manufacturing processes are already determined. This overcomes the time and risk required to establish those activities.
The trial design has 250 ambulatory patients randomized into two treatment groups where half will receive tafenoquine and half placebo. The study will determine if tafenoquine decreases hospitalization rates and medical follow-up visits within 14 days of treatment.
The DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical’s (JPM CBRN Medical) investment in tafenoquine will support the development of a safe, effective treatment against COVID-19 by repurposing the FDA-approved drug. Depending on data from future clinical studies, the drug may also work as a post-exposure prophylaxis.
The U.S. Army Medical Materiel Development Activity (USAMMDA) and 60P first entered into a cooperative research and development agreement in 2014, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. After becoming the first anti-malarial product in over 18 years to gain approval from the FDA, 60P made their first significant shipment of tafenoquine to the U.S. Army in 2019.
“The possibility of repurposing tafenoquine for a COVID-19 indication will continue our advancement in the fight against this disease,” said Col. Ryan Eckmeier, the Joint Project Manager for CBRN Medical. “Enabling these trials improves our goal to protect the warfighter, maintain mission readiness and support the whole-of-government effort during this pandemic.”
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About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.