Houston biotech receives up to $6M federal grant for COVID-19 treatment

DOD delivered

Houston-based Pulmotect announced a grant from the U.S. Department of Defense that will fund two COVID-19 drug trials. Photo via Getty Images

The Pentagon is putting its financial power behind two COVID-19 clinical trials led by Houston-based biotech company Pulmotect Inc.

The U.S. Department of Defense is pumping as much as $6 million into the pair of Phase 2 trials, which involve a total of 300 U.S. participants, according to a January 27 news release from Pulmotect. When it's inhaled, Pulmotect's drug, PUL-042, stimulates the lungs' immune system to fight bacteria, viruses, or fungi that cause respiratory illnesses.

Pulmotect joins a number of Houston organizations that have tapped into Department of Defense funding for research into COVID-19 therapies.

In January, for instance, researchers at the University of Texas Health Science Center at Houston (UTHealth) collected $5.1 million from the department to evaluate whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients.

"It's wonderful that we have COVID-19 vaccinations available now, but they won't directly help patients who are already sick in the hospital or who will become sick in the future," Dr. Holger Eltzschig, chairman of Department of Anesthesiology at UTHealth's McGovern Medical School, says in a news release.

Also in January, Houston-based clinical research organization Pharm-Olam LLC sealed a $36.3 million deal with the Department of Defense to conduct a clinical trial of an antibody treatment for inflammatory problems associated with COVID-19.

So far, Pulmotect's PUL-042 has shown promise in battling the coronaviruses that trigger MERS (Middle East respiratory syndrome) and SARS (severe acute respiratory syndrome). The current trials related to the coronavirus that causes COVID-19 are evaluating PUL-042's effect on prevention of infections and reducing the severity of the disease.

Pulmotect initially designed PUL-042 to treat and prevent respiratory complications in cancer patients. But once the coronavirus pandemic set in, the company pivoted to testing the effectiveness of its drug in combatting the virus that causes COVID-19. Last May, the U.S. Food and Drug Administration (FDA) approved Pulmotect's COVID-19 trials.

Pulmotect says PUL-042 someday could be a therapy that's deployed during pandemics, epidemics, and bioterrorism attacks.

Invented at Houston's MD Anderson Cancer Center and at Texas A&M University, PUL-042 has earned patents in 10 countries. The National Institutes of Health, the Cancer Prevention and Research Institute of Texas, and other organizations have supported R&D for PUL-042.

Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector. In September 2019, the company brought aboard Dr. Colin Broom as CEO. He previously was CEO of an Irish biopharmaceutical company.

Thus far, Pulmotect has garnered about $18 million in equity and about $20 million in other funding.

Before the pandemic, Pulmotect was evaluating the effectiveness of PUL-042 in treating patients with mild chronic obstructive pulmonary disease (COPD) who've been exposed to a respiratory virus.

COPD, which affects 30 million Americans, is the No. 3 cause of death in the U.S., according to the COPD Foundation. Pulmotect says 40 percent of COPD-related costs could be avoided by heading off complications and hospitalizations, which usually result from COPD problems caused by a bacterial or viral infection. In this context, the drug is meant to treat cancer patients undergoing chemotherapy whose weakened immune systems make them susceptible to pneumonia.

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

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

clinical trials bound

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.

Saranas Inc. is testing its technology that can detect and track internal bleeding complications. Getty Images

Houston medical device company heads to clinical trials following recent $2.8 million raise

HEalth tech

A Houston-based medical device startup is on a twofold mission to reduce healthcare costs and improve the safety of complex medical procedures involving blood vessels.

Saranas Inc. currently is testing its Early Bird Bleed Monitoring System, which is designed to detect and track bleeding complications related to endovascular procedures. These medical procedures treat problems, such as aneurysms, that affect blood vessels.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, president and CEO of Saranas. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

Dr. Mehdi Razavi, a cardiologist with the Texas Heart Institute at Houston's Texas Medical Center, invented the device. It's being tested by the institute and other medical facilities in the U.S. As many as 100 patients will participate in the clinical trial, which is expected to last several months.

If all goes well, the U.S. Food and Drug Administration will approve Early Bird in 2019, Syed says. Then, the device would be made widely available to medical facilities across the country.

In May, Saranas said it received $2.8 million in funding from investors to enable testing of Early Bird. In all, the startup has collected $12 million from investors. A month after the funding announcement, Saranas was one of 50 startups chosen for the MedTech Innovator program, which nurtures medical technology companies.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals get audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be halted or prevented.

"There is a risk of bleeding that occurs when some of these coronary interventions are performed through the femoral artery, which is in the upper thigh," Syed says.

In a release, Texas Heart Institute cardiologist Dr. Joggy George says internal bleeding "remains the Achilles' heel" of advances in noninvasive endovascular procedures.

Syed says there's an underappreciation for how often bleeding occurs during nonsurgical procedures that provide access to a patient's blood vessels. Each year, doctors perform these procedures on more than 20 million patients in the U.S.; of those, about 1 million experience severe complications from bleeding. Those complications can lead to longer, more expensive hospital stays along with a higher risk of death.

Initially, Saranas is targeting high-risk endovascular procedures done with large sheaths, rather than endovascular procedures performed with sheaths of all sizes, Syed says.

Syed took the helm of Saranas in February 2017. He's spent nearly 20 years in the medical device industry, including four years at Bellaire-based OrthoAccel Technologies Inc.

For the time being, Syed is one of just a handful of employees at Saranas, which was founded in 2013 and has benefited from its affiliation with the Texas Medical Center Innovation Institute. Syed expects to grow the Saranas team in 2019 once the Early Bird gains clearance from the FDA.

During his tenure in the medical device sector, Syed has been "keenly interested" in bringing impactful innovations to the market, such as the Early Bird device.

"It is especially important to me that such innovation not only improves health outcomes but also aims to drive down healthcare costs," he says. "We are in a healthcare environment where if you don't have a health economic benefit coupled with a clinical outcome, it is very challenging to get adoption of new technology."

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These are the events to attend each day during the Houston Tech Rodeo 2021

where to be

For the second year, Houston Exponential has tapped into the Houston innovation ecosystem to coordinate a week of events to speak to the city's startups, investors, and startup development organizations.

Houston Tech Rodeo will feature over 160 events between May 16 to 23 both online and all across town. From panels and meetups to office hours and pitch events, there's a lot to navigate in the second annual week. For a complete list of Tech Rodeo events (most of which are free), head to the website.

Here are the events you should make sure not to miss. (InnovationMap is a partner for the event.)

Note: You must register for HTR to be able to register for each event. For that reason, the event pages aren't linked directly. Find the information for each event through the HTR event website under the agenda tab, then sort by the day to find the specific event.

Monday: Gettin' in the Game with Master P: A Fireside Chat

The second annual Houston Tech Rodeo kicks off with hip-hop mogul, actor, producer, entrepreneur, and philanthropist, Percy (Master P) Miller on Monday, May 17, at 8 pm. "Gettin' In the Game with Master P" will be an exclusive fireside chat with the legend himself, interviewed by A-List Angels author and former Forbes editor, Zack O'Malley Greenburg. Hear about Master P's journey going from an international rap artist to a CEO, avid investor, and founder of Nemesis RR-- adding diversity in the automotive industry and empowering a culture of dreamers.