According to Pulmotect, the US Department of Defense has provided a grant worth up to $6 million for the completion of two Phase-2 clinical trials of the company’s PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19. In May 2020, Pulmotect announced that it had gotten FDA permission for the two trials.
The studies, which both started in June 2020, are titled, “A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2” and “A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection.” The study evaluating the ability of PUL-042 to prevent transmission is expected to enroll 200 subjects; the treatment study is expected to enroll 100 patients in the early stages of COVID-19 infection.
Pulmotect CEO Colin Broom said, “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 US. We appreciate the support to evaluate PUL-042, which not only has the potential to be effective against SARS-CoV-2 but also has potential for use against other pathogens that infect the respiratory tract. When delivered by inhalation, PUL-042 activates the innate immune system, the front-line of infection defense, to fight off a wide range of respiratory pathogens. We have a development program to evaluate the effect of PUL042 in the treatment and prevention of respiratory complications in cancer patients; however, given the current pandemic we have mobilized our resources towards evaluating the effect of PUL-042 against SARS-CoV-2 infection.”
Read the Pulmotect press release.
