Pulmotect said that it plans to initiate two Phase 2 trials of its PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19 within a week after getting the go-ahead from the FDA. In January 2020, the company announced that preclinical studies of PUL-042, which is made up of Toll-like receptor agonists, demonstrated that it could protect against coronavirus infection and reduce viral load in the lungs post-infection.
Pulmotect CEO Colin Broom explained, “Both clinical trials are placebo-controlled to objectively evaluate safety and efficacy. In the first study, up to four doses of PUL-042 or placebo will be administered to 200 subjects by inhalation over a ten day period to evaluate the prevention of infection and reduction in severity of COVID-19. In the second study, 100 patients with early symptoms of COVID-19 will receive the treatment administered up to three times over six days. In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042.”
Broom added, “We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face. Our development program to prevent respiratory infection and complications in cancer patients would support this potential, however, given the current pandemic, we have mobilized our resources towards directly evaluating the effect of PUL042 against SARS-CoV-2 infection.”
Read the Pulmotect press release.
