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

 
 

Adrianne Stone has joined Capital Factory's Houston operations as the company prioritizes digital startup interaction. Photo courtesy of Capital Factory

For years, Capital Factory has existed to promote innovation and grow startups across Texas and has expanded from its headquarters in Austin to Dallas, Houston, and beyond. In light of COVID-19, the organization has pivoted to make sure it can work with startups remotely and online.

"I think Capital Factory has successfully embraced virtual first," says Bryan Chambers, vice president of the accelerator and fund at Capital Factory. "I think it's gone well and it feels like we're just hitting our stride."

Chambers admits that the onset of the coronavirus had a great effect on Capital Factory — SXSW being canceled did its damage on the organization, which has a huge presence every year. However, cross-state startup collaboration is the driving force behind Capital Factory's Texas Manifesto.

"We're one big state, and we're one big startup ecosystem," Chambers says. "The resources across Dallas, Houston, Austin, North Texas, and San Antonio are available for everybody. Candidly, COVID aligns with that. There's no better time — COVID is erasing the boundaries in a virtual world."

In addition to navigating the transition to virtual operations, Capital Factory has also introduced its newest Houston staff member, as Adrianne Stone has started this week as venture associate for the organization. Stone received her Ph.D in Translational Biology and Molecular Medicine from Baylor College of Medicine before heading out to the West Coast and working at 23andme. She brings both her experience with health tech and Silicon Valley to her position.

"The mindset in Silicon Valley is different from how it is here in Texas — in good ways and bad ways. It was interesting to be exposed to a very potent startup vibe," Stone tells InnovationMap. "I'm looking forward to being able to meet all the cool companies, founders, and investors we have here in the Houston area."

Stone replaces Brittany Barreto, who helped in coordinating her replacement and is staying on part-time for the rest of August to help with training and immersion into the ecosystem. Barreto, who is one of the founders of the recently launched startup masterclass Founder's Compass, has also introduced a new brand called Femtech Focus, that includes a podcast where she talks to innovators in the women's health and wellness space.

"I'm ready to get back into the founder's saddle," Barreto says, adding that there's more to come for Femtech Focus.

Throughout her tenure, Barreto has overseen Capital Factory's Houston portfolio companies — both identifying potential investment opportunities and connecting startups to resources and mentors. She passes the torch to her former BCM classmate, and says she's excited to do so to a fellow Ph.D.

"The last year and a half, I've working really hard on laying this foundation. I don't want all that hard work to go away, so I cared a lot about who was going to take my position," she says. "I wanted to make sure that all my founders had someone who cared about them as much as I do."

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