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.
PUL-042, a synergistic combination of two toll-like receptor agonists, activates the
lungs’ surface immune system. As microbes, including viruses, land on the epithelial cells of the lung lining, they are destroyed on-contact by antimicrobial peptides and reactive oxygen species (ROS), including superoxides, that are released by epithelial cells. PUL042 has demonstrated protection against a broad range of respiratory pathogens in preclinical models, including the coronaviruses that cause MERS and SARS.
“We are delighted to receive funding from the Department of Defense to complete these clinical trials, both of which are enrolling participants at clinical sites in
the U.S.,” said Dr. Colin Broom, CEO of Pulmotect. “We appreciate the support to evaluate PUL-042, which not only has the potential to be effective against SARS-CoV-2 but also also has potential for use against other pathogens that infect the respiratory tract.”
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 (W15QKN-16-9-1002, Project #MCDC 2006-002).
“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.”
Pulmotect is developing PUL-042, a clinical stage, first-in-class, inhaled, immunomodulatory agent. A synergistic agonist that amplifies the innate immune defenses of the lung epithelial mucosa to provide broad-spectrum, pathogen-agnostic protection against respiratory infections. Invented at UT MD Anderson Cancer Center/Texas A&M University, PUL-042 has patents issued in 10 countries, both as a stand-alone composition of matter product and in combination with antivirals. PUL-042 R&D has been supported by the National Institutes of Health (NIAID, NIGMS), the Cancer Prevention and Research Institute of Texas (CPRIT), and other funding agencies.
