» Houston researchers test drug to help health workers.
Houston firm planning for trials next week; PUL-042 might shield doctors and nurses
A Houston company is developing a drug that could protect people in close contact with patients who have COVID-19 from contracting the illness caused by the new coronavirus.
The drug, delivered as an aerosol known as PUL-042, was created by biopharmaceutical company Pulmotect, MD Anderson Cancer Center and Texas A&M, which have worked together to develop the drug for more than a decade. PUL-042 has been tested on mice and has had limited human trials in the United Kingdom and at that point would usually be at least a year away from approval by the Food and Drug Administration.
Pulmotect plans to launch clinical trials testing the safety and effectiveness of the drug in humans next week at Houston Methodist, the company said. If successful, it could request expedited approval in the next six months.
If approved, it could provide short-term immunization for doctors, nurses and people in close proximity to COVID-19 patients until a proper vaccine is developed.
“Our lungs are the front line of defense against noxious pathogens,” said Colin Broom, Pulmotect’s chief executive. “Normally we can fight those off. But an overwhelming infection that you get from this virus? You just can’t fight that.”
Pulmotect and its research partners are among the many drug companies and scientists racing to find vaccines and treatment for COVID-19, the illness caused by the new coronavirus. The virus can cause severe pneumonia in patients, who may experience fevers, dry coughs and difficulty breathing, along with possible gastrointestinal symptoms, according to Baylor University researchers.
Pulmotect’s drug works by stimulating a thin layer of tissue that lines the inside of the lungs and training it to be hostile to invading pathogens. It differs from most vaccines because its effect is almost immediate, but temporary, while vaccines can take weeks to develop antibodies that can fight infections but that last for years, if not lifetimes.
Someone taking the PUL-042 would have to inhale it twice a week to maintain its effectiveness, said Dr. Burton Dickey, chair of pulmonary medicine at MD Anderson Cancer Center and one of the leading researchers.
The company has successfully tested the drug on some of the world’s most vicious viruses in mice, including strains of SARS
and MERS, two other coronaviruses. Researchers said it acts like Clorox, killing bacteria, viruses and microorganisms that cause illness.
“You’d expect it to work against any virus,” Dickey said, “but this provides proof it works against highly virulent coronaviruses.”
The aerosol has moved to clinical trials in the U.K. examining how safe the drug is for smokers who have respiratory issues. Like other vaccines and drugs that could treat COVID-19, two things are keeping PUL-042 from becoming consumer-ready: money and federal approval.
Seeking fast track
Researchers have asked the FDA to approve the drug in time to address the global pandemic. Broom said they have also turned to the National Institute of Allergy and Infection Diseases and the U.S. Biomedical Advanced Research and Development Authority in hopes they can fast-track their drug into clinical trials in the U.S.
Approval from one of those federal agencies could mean a grant to study how it would work with people who could be exposed to the coronavirus. The company, which has raised $28 million over the last 13 years, has secured funding from its investors for a COVID-19 trial.
Pivot from cancer
Researchers estimated that the trial could be completed within the year with just $5 million in funding, if not sooner, given the jump in cases worldwide.
“At the rate cases are happening,” Dickey said, “you could be seeing in a few weeks if it’s effective.”
Pulmotect had originally pitched itself to the FDA as a drug that could help cancer patients who are more susceptible to respiratory infections. It’s possible, Broom and Dickey said, that as the public health crisis grows, federal officials will support funding the drug as a part of the fight against the new coronavirus.
“We need to pivot,” Broom said, “and really evaluate PUL-042 in this pandemic.”