HOUSTON– Pulmotect, Inc., a clinical-stage biotechnology company, announced results from the second of two Phase 2 clinical trials undertaken in the United States with the support of the U.S. Department of Defense (DOD) to evaluate PUL-042 against COVID-19. Results from these trials support the potential of PUL-042 in reducing the severity of COVID-19.
Inhaled PUL-042 stimulates the lung’s powerful immune system to protect against a wide range of respiratory pathogens in multiple animal models. In the two Phase 2 trials, PUL-042 was evaluated in one trial as preemptive treatment in patients with early, symptomatic infection and in a second trial in the prophylactic settings in subjects with known exposure to SARS-CoV-2.
“We now have data from over 200 subjects treated with PUL-042,” said Dr. Colin Broom, CEO of Pulmotect. “Based on these data and the remarkable activity of PUL-042 in animal models we believe that PUL-042 has potential for treatment of COVID-19 irrespective of future SARS-CoV-2 variants and supports the clinical proof-of-concept for protection against respiratory pathogens in other patient populations.”
The most recent trial entitled “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” randomized 217 subjects with exposure to SARS-CoV-2 who were asymptomatic and not known to be infected at the time of enrollment. PUL-042 was administered as a single dose on Days 1, 3, 6, and 10 of the trial and was well tolerated though 28 days of subject follow up. Subjects were tested for SARS-CoV-2 using a nasopharyngeal PCR test at study enrollment and again after 15 and 28 days. Assessments were made at regular intervals using the Ordinal Scale for Clinical Improvement (OSCI), a nine-point scale proposed by the World Health Organization and symptom scores. In total, 12 subjects were found to be positive for SARS-CoV-2 during the trial:
- Six subjects were positive at study entry; three subjects in each treatment arm. All three PUL-042 treated subjects cleared virus by Day 15 of the trial compared to none of the three placebo treated subjects.
- Six subjects became positive during the trial, three in each treatment group.
There was no statistically significant difference between treatment groups in the primary endpoint of change in OSCI although in the prospectively defined subgroup of males were there was a significant difference in favor of PUL-042 (p=0.04).
A previously reported 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, symptomatic disease. PUL-042 was administered as a single dose on Days 1, 3 and 6 of the trial and was well tolerated over 28 days of patient follow up. Few patients deteriorated based on assessment of OSCI however, three patients were hospitalized for progression of COVID-19. Two hospitalized patients in the placebo arm both required intensive care compared to the one hospitalized patient in the PUL-042 arm, who had received a single dose of PUL-042 and did not require intensive care.
Prospectively defined endpoints and analyses in that trial included evaluation of the cardinal symptoms of COVID-19: cough, shortness of breath, respiratory symptoms (cough and shortness of breath) and fatigue. 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.
PUL-042 was well tolerated with a low incidence of adverse effects with no drug related serious adverse events reported in either trial and no deaths.