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

clinical trials bound

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.

These Houston startups have created health care-related solutions amid the coronavirus outbreak. Getty Images

These 7 Houston health tech companies are providing COVID-19 solutions

startups to the rescue

It's all hands on deck in Houston in the battle against coronavirus — and local biotech startups have risen to the occasion.

From mental health solutions and online portals to virtual medicine and new treatments, these Houston companies have recently launched or pivoted to new options in health care.

Mental Health Match

Ryan Schwartz is offering free counseling to Texans. Photo courtesy of Mental Health Match

Mental Health Match, a Houston-based startup that uses tech to easily connect people to mental health professionals, has announced the opportunity for 100 Texas residents to get their first appointment free and remotely.

The company cites data that shows:

  • A 78 percent increase in Texans who are concerned about their marriage
  • A 71 percent increase in Texans concerned with their parenting or their children
  • A 35 percent spike in Texans feeling panicked

"You might be practicing social distancing, but you are not alone. It is easier to make it through this together if you can get support and guidance from a skilled professional. That's why we're working with therapists across Texas to provide a free session to individuals who need it most," says Ryan Schwartz, founder of Mental Health Match, in a news release.

Texans can apply for the free sessions online on a first-come, first-served basis.

Medical Informatics Corp.

Medical Informatics Corp.'s Sickbay platform can monitor patients from afar. Photo via michealthcare.com

Houston-based Medical Informatics has created a virtual ICU program, called Sickbay, and the tech tool is being used to remotely monitor patients in Houston Methodist. The program works around the clock from a control hub to use artificial intelligence and algorithms to monitor patients.

The company, which recently moved into its office in TMCx+, announced major growth in January, just ahead of the coronavirus outbreak.

"We designed our Sickbay platform to give lost data back to doctors, nurses and other members of the care team so they could save more lives," says Vincent Gagne, vice president of product for MIC, in a news release. "In fact, our apps are built in collaboration with our clients, such as Texas Children's Hospital and Houston Methodist. Having these facilities blocks away from our headquarters accelerates that collaboration and development."

MolecularMatch

MolecularMatch is bringing together COVID-19 information and trials. Photo via molecularmatch.com

MolecularMatch, a Houston startup focused on clinical informatics, has launched a free portal that accumulates research and clinical trials for COVID-19. The company is a tenant of TMCx+ and a portfolio company of Houston-based venture capital group GOOSE.

"The number of therapeutic cures and vaccines being tested are growing at an astounding rate," says Eric Pulaski, CEO at MolecularMatch, in a news release. "Our tools make it easier for clinicians and patients to find the help they need. Hopefully, we can help save lives by shortening the time it takes to get more patients into clinical trials and by speeding up research to find cures and vaccines."

The product uses the company's artificial intelligence-backed curation platform and is updated every two to three days.

Luminare

Luminare Inc. pivoted to quickly create an online COVID-19 screening tool, and local governments have tapped into the resource.Andriy Onufriyenko/Getty Images

Founded in 2014, Houston-based health care software startup Luminare Inc. seeks to prevent sepsis, a life-threatening reaction to a host of infections that causes about one-third of U.S. hospital deaths. Recently, though, Luminare pivoted to address another health concern — the threat of the novel coronavirus.

After the novel coronavirus surfaced, Luminare retooled its sepsis-detection platform to create a free online self-assessment test for people who suspect they've contracted the virus. The test, available at CheckForCorona.com, helps someone figure out whether they should seek a coronavirus test.

An online screening typically takes less than two minutes. The confidential, secure assessment complies with guidelines from the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Based on your assessment results, you might be directed to contact your local health department or, in the worst-case scenario, call 911. Click here to read more.

Manatee

Manatee users can sign up for three months free. Photo via getmanatee.com

Denver-based Manatee was just announced to be selected for the 2020 TMCx cohort, and — while programming is beginning virtually — the startup will be enroute to Houston as soon as it's safe. Manatee focuses on providing connected, everyday therapy for kids.

In light of the effects of COVID-19 on both parents and children, Manatee has allowed users to register for three months free. Individuals can apply online.

Moleculin Biotech Inc.

Houston-based Moleculin, which works on oncology treatment, has filed a patent for its treatment to battle the coronavirus. Getty Images

Houston-based Moleculin Biotech Inc., a clinical stage pharmaceutical company that typically focuses on cancer treatment, announced that it has filed for a new patent for its use of one of its products to be used against the coronavirus and other potential viruses.

This patent application is for Moleculin's WP1122, and the company has entered into a partnership with a major Texas university to advance its research.

"We've actually been working on the antiviral potential of WP1122 for some time now," says Walter Klemp, Moleculin's chairman and CEO, in a news release, "but the rise of COVID-19 has obviously placed a new sense of urgency on what we are doing. We hope to be generating animal data on WP1122's antiviral potential in the near term."

Pulmotech Inc.

Pulmotect, a clinical-stage biotechnology company based in Houston, is testing a drug that could be useful in mitigating the threats of the coronavirus, which is currently been recognized as a global health emergency. Getty Images

Experiments conducted by clinical-stage, Houston-based biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

In the Galveston experiments, a single inhaled dose of PUL-042 protected lab mice from the SARS virus, and it greatly reduced the amount of virus in their lungs after the mice became infected with SARS or MERS.

"With the risks of virulent coronaviruses and other threats increasing, as shown by the recent outbreak in Wuhan that has already spread from China to other countries including the United States, Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of current and emerging pathogens and protecting vulnerable populations," says CEO Dr. Colin Broom in a news release. Click here to read more.

Pulmotect, a clinical-stage biotechnology company based in Houston, is testing a drug that could be useful in mitigating the threats of the coronavirus, which is currently been recognized as a global health emergency. Getty Images

Houston biotech company is creating a drug that could fight the coronavirus

Med tech

A drug being developed by a Houston biopharmaceutical company eventually could help combat what the World Health Organization has proclaimed a global health emergency.

Experiments conducted by clinical-stage biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

In the Galveston experiments, a single inhaled dose of PUL-042 protected lab mice from the SARS virus, and it greatly reduced the amount of virus in their lungs after the mice became infected with SARS or MERS.

"With the risks of virulent coronaviruses and other threats increasing, as shown by the recent outbreak in Wuhan that has already spread from China to other countries including the United States, Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of current and emerging pathogens and protecting vulnerable populations," says CEO Dr. Colin Broom in a news release.

The ability of PUL-042 to ward off the newest type of coronavirus, 2019-nCoV, hasn't been tested yet. However, the drug eventually could help prevent the new virus from spreading, says Broom, who joined Pulmotect as CEO last fall. A separate study would be required to evaluate PUL-042 in patients exposed to 2019-nCoV, he says.

"PUL-042 has the potential to prevent and treat respiratory complications in many high-risk patient populations, including those where no effective therapies are currently available, as is the case with the current coronavirus outbreak," Brenton Scott, president and chief operating officer of Pulmotect, says in the release.

Since its discovery in late December 2019 in Wuhan, China, nearly 9,800 people around the world were infected with 2019-nCoV as of January 31, The New York Times reported. Of those people, more than 200 died. On January 30, the World Health Organization (WHO) declared the virus outbreak a global health emergency.

No specific treatment or cure for 2019-nCoV virus is available. This virus is among seven known coronaviruses.

Symptoms of the Wuhan coronavirus include fever, cough, and shortness of breath, according to the U.S. Centers for Disease Control and Prevention (CDC). The virus can cause pneumonia, SARS, kidney failure, or even death, the Virginia Department of Health says.

PUL-042 "would be a great tool to have available for future outbreaks and epidemics, in addition to being used more routinely for more common infections," Broom says.

Fighting coronaviruses is a potential byproduct of PUL-042.

Initially, Pulmotect is focusing development of PUL-042 on the prevention and treatment of respiratory complications suffered by cancer patients with suppressed immune systems. Phase 1 clinical trials already have taken place in the U.S., and Phase 2 clinical trials are scheduled for later this year.

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 prone 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.

Broom says PUL-042 is a few years away from being considered for approval by the U.S. Food and Drug Administration (FDA).

To date, Pulmotect has raised more than $28 million in outside funding. Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector.

Patents for PUL-042, invented by MD Anderson Cancer Center and Texas A&M University, have been issued in nine countries.

A Houston biotech company has a new CEO and is ready for growth. Getty Images

Houston biopharmaceutical company brings on new CEO to grow company

Head honcho

With a veteran of the biopharmaceutical industry now aboard as its CEO and an executive at pharmaceutical giant AstraZeneca now serving on its board, Houston-based biopharmaceutical company Pulmotect Inc. is poised for progress.

In September, Dr. Colin Broom joined Pulmotect as CEO. He previously was CEO of Ireland-based Nabriva Therapeutics plc, a biopharmaceutical company that went public in 2015. During Broom's tenure at Nabriva, he helped develop the recently approved drug Xenleta, which treats bacterial pneumonia. Before that, he was chief scientific officer at Pennsylvania-based pharmaceutical company ViroPharma Inc., which Massachusetts-based Shire plc purchased for $4.2 billion in 2014.

Broom's hiring came on the heels of Kumar Srinivasan being named to Pulmotect's board of directors. Srinivasan is vice president of United Kingdom-based AstraZeneca and is its global head of business development and licensing for biopharmaceuticals R&D.

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

"Attracting such a highly regarded and proven CEO as Colin is a clear signal of the power and potential of Pulmotect's development program," Pulmotect's executive chairman, Leo Linbeck III, founder and chairman of Fannin, says in a release. "Under his leadership, I'm confident that we will advance our technology further into the clinic and closer to the marketplace. His addition is a real game-changer for the company."

Both Broom and Srinivasan are focusing on clinical trials for Pulmotect's PUL-042 product, an inhaled therapy that holds the potential to prevent or treat respiratory infections caused by bacteria, viruses, or fungi. The current Phase 2 trial is evaluating the effectiveness of PUL-042 in treating patients with mild chronic obstructive pulmonary disease (COPD) who've been exposed to a respiratory virus. The current trial is supposed to be followed by additional Phase 2 trials.

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 preventing complications and hospitalizations, which typically result from COPD problems triggered by a bacterial or viral infection. PUL-042 could substantially decrease those complications, the company says.

Pulmotect seeks to gear PUL-042 toward patients with cancer who are undergoing chemotherapy, as their weakened immunity makes them highly susceptible to pneumonia, Broom says. If the product proves effective with those patients, then people at risk of developing respiratory infections also might benefit from it, including COPD patients and flu patients, he says.

To date, Pulmotect has raised more than $28 million in funding. That includes about $18 million in research grants, including a $7 million grant from the Cancer Prevention and Research Institute of Texas, as well as seven grants from the Small Business Innovation Research program.

Two of Pulmotect's three full-time employees work in Houston, and a team of consultants supports their work, Broom says. A small number of employees might be added during the current Phase 2 trial. Hiring would need to be ramped up if the Phase 2 trial demonstrates that PUL-042 works, he says.

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Texas university's innovative 'WaterHub' will dramatically reduce usage by 40%

Sustainable Move

A major advancement in sustainability is coming to one Texas university. A new UT WaterHub at the University of Texas at Austin will be the largest facility of its kind in the U.S. and will transform how the university manages its water resources.

It's designed to work with natural processes instead of against them for water savings of an estimated 40 percent. It's slated for completion in late 2027.

The university has had an active water recovery program since the 1980s. Still, water is becoming an increasing concern in Austin. According to Texas Living Waters, a coalition of conservation groups, Texas loses enough water annually to fill Lady Bird Lake roughly 89 times over.

As Austin continues to expand and face water shortages, the region's water supply faces increased pressure. The UT WaterHub plans to address this challenge by recycling water for campus energy operations, helping preserve water resources for both the university and local communities.

The 9,600-square-foot water treatment facility will use an innovative filtration approach. To reduce reliance on expensive machinery and chemicals, the system uses plants to naturally filter water and gravity to pull it in the direction it needs to go. Used water will be gathered from a new collection point near the Darrell K Royal Texas Memorial Stadium and transported to the WaterHub, located in the heart of the engineering district. The facility's design includes a greenhouse viewable to the public, serving as an interactive learning space.

Beyond water conservation, the facility is designed to protect the university against extreme weather events like winter storms. This new initiative will create a reliable backup water supply while decreasing university water usage, and will even reduce wastewater sent to the city by up to 70 percent.

H2O Innovation, UT’s collaborator in this project, specializes in water solutions, helping organizations manage their water efficiently.

"By combining cutting-edge technology with our innovative financing approach, we’re making it easier for organizations to adopt sustainable water practices that benefit both their bottom line and the environment, paving a step forward in water positivity,” said H2O Innovation president and CEO Frédéric Dugré in a press release.

The university expects significant cost savings with this project, since it won't have to spend as much on buying water from the city or paying fees to dispose of used water. Over the next several years, this could add up to millions of dollars.

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A version of this story originally appeared on our sister site, CultureMap Austin.

Texas female-founded companies raised more than $1 billion in 2024, VC data shows

by the numbers

Female-founded companies in Dallas-Fort Worth may rack up more funding deals and more money than those in Houston. However, Bayou City beats DFW in one key category — but just barely.

Data from PitchBook shows that in the past 16 years, female-founded companies in DFW collected $2.7 billion across 488 deals. By comparison, female-founded companies in the Houston area picked up $1.9 billion in VC through 343 deals.

Yet if you do a little math, you find that Houston ekes out an edge over DFW in per-deal values. During the period covered by the PitchBook data, the value of each of the DFW deals averaged $5.53 million. But at $5,54 million, Houston was just $6,572 ahead of DFW for average deal value.

Not surprisingly, the Austin area clobbered Houston and DFW.

During the period covered by the PitchBook data, female-founded companies in the Austin area hauled in $7.5 billion across 1,114 deals. The average value of an Austin deal: more than $6.7 million.

Historically, funding for female-established companies has lagged behind funding for male-established companies. In 2024, female-founded companies accounted for about one-fourth of all VC deals in the U.S., according to PitchBook.

PitchBook noted that in 2024, female-founded companies raised $38.8 billion, up 27 percent from the previous year, but deal count dropped 13.1 percent, meaning more VC for fewer startups. In Texas, female-founded companies brought in $1.3 billion last year via 151 deals. The total raised is the same as 2023, when Texas female founders got $1.3 billion in capital across 190 deals.

“The VC industry is still trying to find solid footing after its peak in 2021. While some progress was made for female founders in 2024, particularly in exit activity, female founders and investors still face an uphill climb,” says Annemarie Donegan, senior research analyst at PitchBook.

Here are 3 Houston innovators to know right now

Innovators to Know

Editor's note: These Houston innovators are making big strides in the fields of neurotechnology, neurodevelopmental diagnosis, and even improving the way we rest and recharge.

For our latest roundup of Innovators to Know, we meet a researcher who is working with teams in Houston and abroad to develop an innovative brain implant; a professor who has created an AI approach to diagnosis; and a local entrepreneur whose brand is poised for major expansion in the coming years.

Jacob Robinson, CEO of Motif Neurotech

Houston startup Motif Neurotech has been selected by the United Kingdom's Advanced Research + Invention Agency (ARIA) to participate in its inaugural Precision Neurotechnologies program. The program aims to develop advanced brain-interfacing technologies for cognitive and psychiatric conditions. Three Rice labs will collaborate with Motif Neurotech to develop Brain Mesh, which is a distributed network of minimally invasive implants that can stimulate neural circuits and stream neural data in real time. The project has been awarded approximately $5.9 million.

Motif Neurotech was spun out of the Rice lab of Jacob Robinson, a professor of electrical and computer engineering and bioengineering and CEO of Motif Neurotech.

Robinson will lead the system and network integration and encapsulation efforts for Mesh Points implants. According to Rice, these implants, about the size of a grain of rice, will track and modulate brain states and be embedded in the skull through relatively low-risk surgery. Learn more.

Dr. Ryan S. Dhindsa, Dhindsa Lab

Dr. Ryan S. Dhindsa, assistant professor of pathology and immunology at Baylor and principal investigator at the Jan and Dan Duncan Neurological Research Institute at Texas Children’s Hospital, and his team have developed an artificial intelligence-based approach that will help doctors to identify genes tied to neurodevelopmental disorders. Their research was recently published the American Journal of Human Genetics.

Dhindsa Lab uses “human genomics, human stem cell models, and computational biology to advance precision medicine.” The diagnoses that stem from the new computational tool could include specific types of autism spectrum disorder, epilepsy and developmental delay, disorders that often don’t come with a genetic diagnosis.

“Although researchers have made major strides identifying different genes associated with neurodevelopmental disorders, many patients with these conditions still do not receive a genetic diagnosis, indicating that there are many more genes waiting to be discovered,” Dhindsa says. Learn more.

Khaliah Guillory, Founder of Nap Bar

From nap research to diversity and inclusion, this entrepreneur is making Houston workers more productiveFrom opening Nap Bar and consulting corporations on diversity and inclusion to serving the city as an LGBT adviser, Khaliah Guillory is focused on productivity. Courtesy of Khaliah Guillory

Khalia Guillory launched her white-glove, eco-friendly rest sanctuary business, Nap Bar, in Houston in 2019 to offer a unique rest experience with artificial intelligence integration for working professionals, entrepreneurs and travelers who needed a place to rest, recharge and rejuvenate.

Now she is ready to take it to the next level, with a pivot to VR and plans to expand to 30 locations in three years.

Guillory says she’s now looking to scale the business by partnering with like-minded investors with experience in the wellness space. She envisions locations at national and international airports, which she says offer ripe scenarios for patrons needing to recharge. Additionally, Guillory wants to build on her initial partnership with UT Health by going onsite to curate rest experiences for patients, caregivers, faculty, staff, nurses and doctors. Colleges also offer an opportunity for growth. Learn more.

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