clinical trials bound

Houston biotech company gets green light from FDA to test coronavirus-fighting drug

Pulmotect is headed to clinical trials to verify how its drug fights against COVID-19. Getty Images

Houston biotech company Pulmotect Inc. has embarked on two clinical drug trials that could create weapons for the battle against the novel coronavirus.

Pulmotect gained permission from the U.S. Food and Drug Administration to test its inhaled drug, PUL-042, as a way to prevent coronavirus infections and to slow the early progression of COVID-19, the potentially fatal disease caused by the novel coronavirus. Pulmotect developed PUL-042 to activate the lungs' front-line defense against respiratory infections, and now it's being enlisted in the race to devise coronavirus treatments and cures.

"We have demonstrated PUL-042's unique ability to stimulate the immune system in the lungs to protect against a wide range of pathogens in multiple animal models," Dr. Colin Broom, CEO of Pulmotect, says in a May 7 release. "Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of [the coronavirus] and future emerging pathogens, and protecting vulnerable populations."

Unlike a vaccine, which typically takes 10 to 15 years to bring to the market, PUL-042 promises much faster deployment as scientists and health care workers wage war against COVID-19.

Each of the two clinical trials, both in the second phase, is being conducted at 10 sites across the U.S., including locations in Houston. In all, 20 sites are participating. Money for the trials came from the company's recently completed $12 million round of series B funding.

Pulmotect's partner in the trials is Covington, Kentucky-based CTI Clinical Trial and Consulting Services Inc. PARI Respiratory Equipment Inc., whose North American headquarters is in Midlothian, Virginia, is supplying medical equipment known as nebulizers to administer Pulmotect's inhaled drug.

"Both clinical trials are placebo-controlled to objectively evaluate safety and efficacy," Broom says in a May 5 release.

"In the first study, up to four doses of PUL-042 or placebo will be administered to 200 subjects by inhalation over a 10-day period to evaluate the prevention of infection and reduction in severity of COVID-19. In the second study, 100 patients with early symptoms of COVID-19 will receive the treatment administered up to three times over six days. In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042."

Previous experiments conducted by Pulmotect indicate PUL-042 effectively protects mice against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which are caused by coronaviruses that differ from the COVID-19 virus. Researchers performed those tests at the University of Texas Medical Branch at Galveston.

PUL-042 initially was developed to fight respiratory problems in cancer patients undergoing chemotherapy, which weakens the immune system. But the drug offers the potential to prevent or treat an array of respiratory infections caused by viruses, bacteria, or fungi.

"We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face," Broom says.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are susceptible to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Researchers at MD Anderson Cancer Center and Texas A&M University invented Pulmotect's PUL-042, which holds patents in 10 countries. Pulmotect, founded in 2007, emerged from Houston's Fannin Innovation Studio, which fosters early stage companies in the life sciences sector.

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Building Houston

 
 

A new report finds Houston a top city for business friendliness and connectivity. Photo via Getty Images

Houston, the future looks bright.

A new study from the fDi Intelligence division of the Financial Times places Houston at No. 7 among the top major cities of the future for 2021-22 across North, South, and Central America. Among major cities in the Americas, Houston appears at No. 3 for business friendliness and No. 4 for connectivity.

"Houston is known as one of the youngest, fastest-growing, and most diverse cities anywhere in the world. I am thrilled that we continue to be recognized for our thriving innovation ecosystem," Houston Mayor Sylvester Turner is quoted as saying in the fDi study.

Toronto leads the 2021-22 list of the top major cities in the Americas, followed by San Francisco, Montreal, Chicago, and Boston.

The rankings are based on data in five categories:

  • Economic potential
  • Business friendliness
  • Human capital and lifestyle
  • Cost effectiveness
  • Connectivity

Houston's no stranger to the list. Last year, the city ranked No. 3 on the same study, and in 2019, claimed the No. 5 spot.

"The fact that Houston consistently ranks among the top markets for foreign direct investment speaks to our region's connectivity and business-friendly environment," says Susan Davenport, chief economic development officer at the Greater Houston Partnership. "Many of the industry sectors we target for expansion and relocation in Houston are global in nature — from energy 2.0 and life sciences to aerospace and digital tech. The infrastructure and diverse workforce that make these prime growth sectors for us among domestic players are equally attractive to international companies looking to establish or strengthen ties in the Americas."

International trade is a cornerstone of the Houston area's economy. In 2020, the region recorded $129.5 billion in exports, according to the Greater Houston Partnership. China ranked as the region's top trading partner last year, followed by Mexico, Brazil, Korea, Germany, the Netherlands, India, Japan, the United Kingdom, and Italy.

Houston's role as a hub for foreign trade and international business "is likely to support the region's economic recovery in the months and years ahead," the partnership noted in May.

"We talk often of Houston as a great global city — one that competes with the likes of London, Tokyo, São Paulo, and Beijing. But that's only possible because of our infrastructure — namely our port — and our connections around the world," Bob Harvey, president and CEO of the partnership, said last month. "Houston's ties abroad remain strong."

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