Houston, TX (September 21, 2021) – Pulmotect, Inc., a clinical-stage biotechnology company, announced positive topline results from the first of two Phase-2 clinical trials undertaken with the support of the US Department of Defense (DOD) to evaluate PUL-042 against COVID-19. Patients treated with inhaled PUL-042 had a statistically significant reduction in the time to improvement of the combined respiratory symptoms of cough and shortness of breath. Inhaled PUL-042 stimulates the lung’s innate immune system with the potential to protect against a wide variety of respiratory pathogens. PUL-042 could be directed against all existing and future variants of the SARS-CoV-2 virus, as well as future pandemics. Based on the promising results from this trial and remarkable activity in pre-clinical models, PUL-042 also has potential for use in other patient populations.

 

“I am excited about the topline results with PUL-042 and the shortening of time to symptoms improvement for patients with early COVID-19, which could have significant health and economic benefits as the global pandemic continues to unfold,” said Dr. Colin Broom, CEO of Pulmotect. “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants and has potential utility for other patient populations which we plan to explore including immunosuppressed cancer patients.”     

 

The trial entitled “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” randomized 101 patients with early disease in the United States.  PUL-042 was well tolerated when administered as a single dose on Day 1, Day 3 and Day 6 of the trial with 28 days of patient follow up. Two patients were hospitalized with a deterioration from pre-treatment of 2 or more points on the Ordinal Scale for Clinical Improvement, a nine-point scale proposed by the World Health Organization, one in each of the treatment arms. In total, three patients were hospitalized for progression of COVID-19, two in the placebo arm who both required intensive care treatment for 5 days and 9 days and one patient in the PUL-042 arm who was hospitalized for four days having received a single dose of PUL-042 and did not require intensive care.

 

Prospectively defined endpoints and analyses included evaluation of the cardinal symptoms of COVID-19: cough, shortness of breath, respiratory symptoms (cough and shortness of breath) and fatigue. Each individual symptom was scored as 0 (absent), 1 (mild), 2 (moderate) and 3 (severe). There was a statistically significant difference in time to improvement of respiratory symptoms (p=0.0227) using a log-rank comparison of time to symptom improvement. The median time to improvement of respiratory symptoms was 6 days for PUL-042 and 9 days for placebo. Time to complete resolution of respiratory symptoms also trended in favor of PUL-042. There was also a positive effect on time to improvement of cough (p=0.0547). The median time to improvement of cough was 7 days for PUL-042 and 11 days for placebo.

 

PUL-042 was well tolerated with a low incidence of adverse effects with no drug related serious adverse events reported in the trial and no deaths in this patient population. 

 

PUL-042, a first in class, synergistic combination of two toll-like receptor agonists, activates the lungs’ surface innate immune system to inhibit and kill a wide range of respiratory pathogens. 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), that are released by epithelial cells. Activation of the innate immune system also triggers a response from the adaptive immune system. PUL-042 has demonstrated protection against a broad range of respiratory pathogens in pre-clinical models, including the coronaviruses that cause MERS and SARS. With robust pre-clinical protection shown against multiple pathogens even in models with immunocompromised animals and favorable tolerability demonstrated in clinical trials to date, PUL-042 could offer a broad-spectrum therapy for responding to epidemics and pandemics including current and future SARS-CoV-2 variants and has potential use for multiple other indications.  

 

The Phase 2 studies of PUL-042 for COVID-19 are funded in part with federal funds from 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 U.S. Army Contracting Command - New Jersey, under an Other Transaction Agreement (W15QKN-16-9-1002, Project #MCDC 2006-002) awarded to the Medical CBRN Defense Consortium and Pulmotect, Inc.