Researchers believe the drug PUL-042 may work against COVID-19 and other respiratory infections, including all existing and future variants of SARS-CoV-2.
Texas A&M University Science Center, MD Anderson Cancer Center, and Pulmotect report that the drug PUL-042 appears to work against COVID-19 and other respiratory infections. The drug stimulates the innate immune system in the lungs. They believe it might work against all existing and future variants of SARS-CoV-2, the virus that causes COVID-19, in addition to future pandemics.
“We have not found a virus PUL-042 cannot work against in the lungs, in animal studies,” said Dr. Colin Broom, chief executive officer 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. It also has potential utility for other patient populations which we plan to explore, including immunosuppressed cancer patients.”
On September 21, Pulmotect announced positive topline data from the first of two Phase II trials of PUL-042 against COVID-19. The U.S. Department of Defense (DOD) supported the trial. The study demonstrated that patients receiving inhaled PUL-042 had a statistically significant decrease in the time to improvement of combined respiratory symptoms of cough and shortness of breath.
Patients tolerated the drug well when given as a single dose on day 1, day 3, and day 6 of the trial with patient follow-up for 28 days. In total, three patients were hospitalized when their COVID-19 progressed, two in the placebo arm who both required intensive care for five days and nine days, and one patient in the PUL-042 cohort was hospitalized for four days after receiving a single dose of the drug. The patient, however, did not require intensive care.
The drug is a first-in-class, synergistic combination of two toll-like receptor agonists that activate the lung’s surface innate immune system. In addition to COVID-19, in animal models, it has shown protection against the coronaviruses that cause MERS and SARS.
“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,” Broom said. “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 drug was discovered by Magnus Höök, Ph.D., Regents and Distinguished Professor at the Texas A&M Health Institute of Biosciences and Technology, and Burton Dickey, M.D., chair of the pulmonary department at MD Anderson Cancer Center and instructional professor in the Texas A&M Engineering Medicine program.
“The lungs are the point of entry for many viruses and bacteria,” Höök said. “By activating the innate immune defense of the lungs, PUL-042 can provide effective protection against a wide range of deadly pathogens. We believe that if we had this therapy available in December of 2019, we could have prevented the COVID-19 pandemic and avoided the 6 million lives lost.”
The protection the drug offers only seems to last three to five days but can be re-administered once every few days.
