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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Self-driving pizza delivery goes live in Houston

Domino's and Nuro announced their partnership in 2019 — and now the robots are hitting the roads. Photo courtesy of Nuro

After announcing their partnership to work on pizza deliveries via self-driving robots in 2019, Dominos and Nuro have officially rolled out their technology to one part of town.

Beginning this week, if you place a prepaid order from Domino's in Woodland Heights (3209 Houston Ave.), you might have the option to have one of Nuro's R2 robot come to your door. This vehicle is the first do deliver completely autonomously without occupants with a regulatory approval by the U.S. Department of Transportation, according to a news release.

"We're excited to continue innovating the delivery experience for Domino's customers by testing autonomous delivery with Nuro in Houston," says Dennis Maloney, Domino's senior vice president and chief innovation officer, in the release. "There is still so much for our brand to learn about the autonomous delivery space. This program will allow us to better understand how customers respond to the deliveries, how they interact with the robot and how it affects store operations."

Orders placed at select dates and times will have the option to be delivered autonomously. Photo courtesy of Nuro

The Nuro deliveries will be available on select days and times, and users will be able to opt for the autonomous deliveries when they make their prepaid orders online. They will then receive a code via text message to use on the robot to open the hatch to retrieve their order.

"Nuro's mission is to better everyday life through robotics. Now, for the first time, we're launching real world, autonomous deliveries with R2 and Domino's," says Dave Ferguson, Nuro co-founder and president, in the release. "We're excited to introduce our autonomous delivery bots to a select set of Domino's customers in Houston. We can't wait to see what they think."

California-based Nuro has launched a few delivery pilots in Houston over the past few years, including the first Nuro pilot program with Kroger in March 2019, grocery delivery from Walmart that was revealed in December 2019, and pharmacy delivery that launched last summer.

From being located in a state open to rolling out new AV regulations to Houston's diversity — both in its inhabitants to its roadways, the Bayou City stood out to Nuro, says Sola Lawal, product operations manager at Nuro.

"As a company, we tried to find a city that would allow us to test a number of different things to figure out what really works and who it works for," Lawal says on an episode of the Houston Innovators Podcast. "It's hard to find cities that are better than Houston at enabling that level of testing."

Steam the episode here.

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