24 September 2021 - - US-based biotechnology company Pulmotect, Inc has posted positive topline results from the first of two Phase-2 clinical trials undertaken with the support of the US Department of Defense to evaluate PUL-042 against COVID-19, the company said.

Patients treated with inhaled PUL-042 had a statistically significant reduction in the time to the 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 range 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.

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 five days and nine 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, 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 six days for PUL-042 and nine 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, 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 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 US 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.

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 and M University, PUL-042 has patents issued in 27 countries, both as a stand-alone composition of matter product and in combination with antivirals.

PUL-042 R and D has been supported by the National Institutes of Health (NIAID, NIGMS), the Cancer Prevention and Research Institute of Texas (CPRIT), other funding agencies, and the Fannin Innovation Studio.

Houston-based Fannin Innovation Studio is an early-stage life sciences development group focused exclusively on commercializing biotech and medtech technologies. Fannin creates and manages start-ups to develop internal and in-licensed programs.

Fannin has over a dozen active programs, including three in clinical development.