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

 
 

Vanessa Wyche, director of the Johnson Space Center, gave the keynote address at this year's State of Space event. Screenshot via houston.org

Is the Space City poised to continue its reign as an innovative hub for space exploration? All signs point to yes, according to a group of experts.

The Greater Houston Partnership hosted its annual State of Space this week. The virtual event featured a keynote address from Vanessa Wyche, director of NASA Johnson Space Center, and a panel moderated by David Alexander, chair of aerospace and aviation committee at the GHP and the director of the Rice Space Institute.

The conversations focused on the space innovation activity happening in Houston, as well as an update on the industry as a whole has space commercialization continues to develop. All the speakers addressed how Houston has what it takes to remain a hub for the sector.

"The future looks very bright for Houston that we will remain a leader in Houston spaceflight," Wyche says in her address.

Here are a few other memorable moments from the event.

"Houston, I feel, is poised to be a leader. We have led in human space flight, and we will a leader in commercialization."

— Wyche says in her keynote address, which gave a thorough overview of what all NASA is working on at JSC. She calls out specifically how startups are a driving force in commercialization. JSC is working with local accelerator programs at The Ion and MassChallenge.

"These startups help us to connect to tomorrow's space innovation leaders, and gives our team the opportunity to mentor these entrepreneurs as we work to advance both our scientific and technical knowledge," she says.

"The ability to have a place where government, academia, and industry can come together and share ideas and innovation is incredibly powerful."

​— Steve Altemus, president and CEO of Intuitive Machines LLC, specifically talking about the Houston Spaceport, where Intuitive Machines has signed on as a tenant. Altemus adds that a major key to leading space commercialization is a trained workforce, which the spaceport is focused on cultivating.

"We shouldn't discount the character that Houston has from the standpoint as a great place to build a business."

— Tim Kopra, vice president of robotics and space at MDA Ltd., says, adding that Houston is a big city that feels like a small town. "We need to incentivize companies to come and stay," he says.

"Great cities — like great companies — understand that if you're still, you're probably moving backwards. ... I think Houston gets it in that regard."

— Todd May, senior vice president of science and space at KBR, says, adding that Houston realizes it needs to be on the offensive side to bring innovation to the game, positioning the city very well for the future.

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