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.

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Houston engineers develop breakthrough device to advance spinal cord treatment

future of health

A team of Rice University engineers has developed an implantable probe over a hundred times smaller than the width of a hair that aims to help develop better treatments for spinal cord disease and injury.

Detailed in a recent study published in Cell Reports, the probe or sensor, known as spinalNET, is used to explore how neurons in the spinal cord process sensation and control movement, according to a statement from Rice. The research was supported by the National Institutes of Health, Rice, the California-based Salk Institute for Biological Studies, and the philanthropic Mary K. Chapman Foundation based in Oklahoma.

The soft and flexible sensor was used to record neuronal activity in freely moving mice with high resolution for multiple days. Historically, tracking this level of activity has been difficult for researchers because the spinal cord and its neurons move so much during normal activity, according to the team.

“We developed a tiny sensor, spinalNET, that records the electrical activity of spinal neurons as the subject performs normal activity without any restraint,” Yu Wu, a research scientist at Rice and lead author of the study said in a statement. “Being able to extract such knowledge is a first but important step to develop cures for millions of people suffering from spinal cord diseases.”

The team says that before now the spinal cord has been considered a "black box." But the device has already helped the team uncover new findings about the body's rhythmic motor patterns, which drive walking, breathing and chewing.

Lan Luan (from left), Yu Wu, and Chong Xie are working on the breakthrough device. Photo by Jeff Fitlow/Rice University

"Some (spinal neurons) are strongly correlated with leg movement, but surprisingly, a lot of neurons have no obvious correlation with movement,” Wu said in the statement. “This indicates that the spinal circuit controlling rhythmic movement is more complicated than we thought.”

The team said they hope to explore these findings further and aim to use the technology for additional medical purposes.

“In addition to scientific insight, we believe that as the technology evolves, it has great potential as a medical device for people with spinal cord neurological disorders and injury,” Lan Luan, an associate professor of electrical and computer engineering at Rice and a corresponding author on the study, added in the statement.

Rice researchers have developed several implantable, minimally invasive devices to address health and mental health issues.

In the spring, the university announced that the United States Department of Defense had awarded a four-year, $7.8 million grant to the Texas Heart Institute and a Rice team led by co-investigator Yaxin Wang to continue to break ground on a novel left ventricular assist device (LVAD) that could be an alternative to current devices that prevent heart transplantation.

That same month, the university shared news that Professor Jacob Robinson had published findings on minimally invasive bioelectronics for treating psychiatric conditions. The 9-millimeter device can deliver precise and programmable stimulation to the brain to help treat depression, obsessive-compulsive disorder and post-traumatic stress disorder.

Houston clean hydrogen startup to pilot tech with O&G co.

stay gold

Gold H2, a Houston-based producer of clean hydrogen, is teaming up with a major U.S.-based oil and gas company as the first step in launching a 12-month series of pilot projects.

The tentative agreement with the unnamed oil and gas company kicks off the availability of the startup’s Black 2 Gold microbial technology. The technology underpins the startup’s biotech process for converting crude oil into proprietary Gold Hydrogen.

The cleantech startup plans to sign up several oil and gas companies for the pilot program. Gold H2 says it’s been in discussions with companies in North America, Latin America, India, Eastern Europe and the Middle East.

The pilot program is aimed at demonstrating how Gold H2’s technology can transform old oil wells into hydrogen-generating assets. Gold H2, a spinout of Houston-based biotech company Cemvita, says the technology is capable of producing hydrogen that’s cheaper and cleaner than ever before.

“This business model will reshape the traditional oil and gas industry landscape by further accelerating the clean energy transition and creating new economic opportunities in areas that were previously dismissed as unviable,” Gold H2 says in a news release.

The start of the Black 2 Gold demonstrations follows the recent hiring of oil and gas industry veteran Prabhdeep Singh Sekhon as CEO.

“With the proliferation of AI, growth of data centers, and a national boom in industrial manufacturing underway, affordable … carbon-free energy is more paramount than ever,” says Rayyan Islam, co-founder and general partner at venture capital firm 8090 Industries, an investor in Gold H2. “We’re investing in Gold H2, as we know they’ll play a pivotal role in unleashing a new dawn for energy abundance in partnership with the oil industry.”

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This article originally ran on EnergyCapital.

3 Houston innovators to know this week

who's who

Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes an e-commerce startup founder, an industrial biologist, and a cellular scientist.

Omair Tariq, co-founder and CEO of Cart.com

Omair Tariq of Cart.com joins the Houston Innovators Podcast to share his confidence in Houston as the right place to scale his unicorn. Photo via Cart.com

Houston-based Cart.com, which operates a multichannel commerce platform, has secured $105 million in debt refinancing from investment manager BlackRock.

The debt refinancing follows a recent $25 million series C extension round, bringing Cart.com’s series C total to $85 million. The scaleup’s valuation now stands at $1.2 billion, making it one of the few $1 billion-plus “unicorns” in the Houston area.

Cart.com was co-founded by CEO Omair Tariq in October 2020. Read more.

Nádia Skorupa Parachin, vice president of industrial biotechnology at Cemvita

Nádia Skorupa Parachin joined Cemvita as vice president of industrial biotechnology. Photo courtesy of Cemvita

Houston-based biotech company Cemvita recently tapped two executives to help commercialize its sustainable fuel made from carbon waste.

Nádia Skorupa Parachin came aboard as vice president of industrial biotechnology, and Phil Garcia was promoted to vice president of commercialization.

Parachin most recently oversaw several projects at Boston-based biotech company Ginkjo Bioworks. She previously co-founded Brazilian biotech startup Integra Bioprocessos. Read more.

Han Xiao, associate professor of chemistry at Rice University

The funds were awarded to Han Xiao, a chemist at Rice University.

A Rice University chemist has landed a $2 million grant from the National Institute of Health for his work that aims to reprogram the genetic code and explore the role certain cells play in causing diseases like cancer and neurological disorders.

The funds were awarded to Han Xiao, the Norman Hackerman-Welch Young Investigator, associate professor of chemistry, from the NIH's Maximizing Investigators’ Research Award (MIRA) program, which supports medically focused laboratories. Xiao will use the five-year grant to advance his work on noncanonical amino acids.

“This innovative approach could revolutionize how we understand and control cellular functions,” Xiao said in the statement. Read more.

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