NEWS | Jan. 26, 2021

DOD Supports Phase II Clinical Trials Repurposing Inhaled PUL-042 for COVID-19 Prevention and Treatment

By Press Release JPEO-CBRND

The JPM CBRN Medical executed an agreement with Pulmotect, Inc. to study the effectiveness of an existing compound that shows promise against COVID-19.

FORT DETRICK, Md. – January 25, 2021 – The Department of Defense (DOD) awarded a $6 million agreement to Pulmotect, Inc., a clinical-stage biotechnology company, to execute two ongoing Phase II trials addressing COVID-19.

Pulmotect is developing PUL-042, a clinical stage, first-in-class, immunomodulatory agent. PUL-042 is an inhaled compound that may both prevent and treat COVID-19 infection by stimulating host lung epithelial cells to fight off pathogens. If the clinical trials generate positive data, Pulmotect will submit an emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for PUL-042 as a COVID-19 therapeutic in 2021.

The first study will test the prophylactic capabilities of PUL-042 by evaluating the efficacy and safety of the drug in reducing the infection rate of SARS-CoV-2 and its progression to COVID-19. The second is a therapeutic study testing the effectiveness of PUL-042 to reduce the severity of the disease in those with early and/or mild COVID-19 infection. 

The agreement was executed by 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 (JPM CBRN Medical) through the Medical CBRN Defense Consortium, in collaboration with U.S. Army Contracting Command-New Jersey. This study supports the DOD’s mission because repurposing PUL-042 to prevent and treat COVID-19 could prevent hospitalization and progression of severe COVID-19, keeping service members in the fight and maintaining warfighter readiness. 

“The repurposing of this agent advances the fight against COVD-19, with the potential to protect our service members during this unprecedented pandemic,” said Col. Ryan Eckmeier, the Joint Project Manager for CBRN Medical. “Facilitating our government and industry partners to help find a way to tackle this threat is a necessary action to reduce the spread of this disease.”

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.