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.

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Houston researchers make headway on affordable, sustainable sodium-ion battery

Energy Solutions

A new study by researchers from Rice University’s Department of Materials Science and NanoEngineering, Baylor University and the Indian Institute of Science Education and Research Thiruvananthapuram has introduced a solution that could help develop more affordable and sustainable sodium-ion batteries.

The findings were recently published in the journal Advanced Functional Materials.

The team worked with tiny cone- and disc-shaped carbon materials from oil and gas industry byproducts with a pure graphitic structure. The forms allow for more efficient energy storage with larger sodium and potassium ions, which is a challenge for anodes in battery research. Sodium and potassium are more widely available and cheaper than lithium.

“For years, we’ve known that sodium and potassium are attractive alternatives to lithium,” Pulickel Ajayan, the Benjamin M. and Mary Greenwood Anderson Professor of Engineering at Rice, said in a news release. “But the challenge has always been finding carbon-based anode materials that can store these larger ions efficiently.”

Lithium-ion batteries traditionally rely on graphite as an anode material. However, traditional graphite structures cannot efficiently store sodium or potassium energy, since the atoms are too big and interactions become too complex to slide in and out of graphite’s layers. The cone and disc structures “offer curvature and spacing that welcome sodium and potassium ions without the need for chemical doping (the process of intentionally adding small amounts of specific atoms or molecules to change its properties) or other artificial modifications,” according to the study.

“This is one of the first clear demonstrations of sodium-ion intercalation in pure graphitic materials with such stability,” Atin Pramanik, first author of the study and a postdoctoral associate in Ajayan’s lab, said in the release. “It challenges the belief that pure graphite can’t work with sodium.”

In lab tests, the carbon cones and discs stored about 230 milliamp-hours of charge per gram (mAh/g) by using sodium ions. They still held 151 mAh/g even after 2,000 fast charging cycles. They also worked with potassium-ion batteries.

“We believe this discovery opens up a new design space for battery anodes,” Ajayan added in the release. “Instead of changing the chemistry, we’re changing the shape, and that’s proving to be just as interesting.”

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This story originally appeared on EnergyCapitalHTX.com.

FAA demands investigation into SpaceX's out-of-control Starship flight

Out of this world

The Federal Aviation Administration is demanding an accident investigation into the out-of-control Starship flight by SpaceX on May 27.

Tuesday's test flight from Texas lasted longer than the previous two failed demos of the world's biggest and most powerful rocket, which ended in flames over the Atlantic. The latest spacecraft made it halfway around the world to the Indian Ocean, but not before going into a spin and breaking apart.

The FAA said Friday that no injuries or public damage were reported.

The first-stage booster — recycled from an earlier flight — also burst apart while descending over the Gulf of Mexico. But that was the result of deliberately extreme testing approved by the FAA in advance.

All wreckage from both sections of the 403-foot (123-meter) rocket came down within the designated hazard zones, according to the FAA.

The FAA will oversee SpaceX's investigation, which is required before another Starship can launch.

CEO Elon Musk said he wants to pick up the pace of Starship test flights, with the ultimate goal of launching them to Mars. NASA needs Starship as the means of landing astronauts on the moon in the next few years.

TMC med-tech company closes $2.5M series A, plans expansion

fresh funding

Insight Surgery, a United Kingdom-based startup that specializes in surgical technology, has raised $2.5 million in a series A round led by New York City-based life sciences investor Nodenza Venture Partners. The company launched its U.S. business in 2023 with the opening of a cleanroom manufacturing facility at Houston’s Texas Medical Center.

The startup says the investment comes on the heels of the U.S. Food and Drug Administration (FDA) granting clearance to the company’s surgical guides for orthopedic surgery. Insight says the fresh capital will support its U.S. expansion, including one new manufacturing facility at an East Coast hospital and another at a West Coast hospital.

Insight says the investment “will provide surgeons with rapid access to sophisticated tools that improve patient outcomes, reduce risk, and expedite recovery.”

Insight’s proprietary digital platform, EmbedMed, digitizes the surgical planning process and allows the rapid design and manufacturing of patient-specific guides for orthopedic surgery.

“Our mission is to make advanced surgical planning tools accessible and scalable across the U.S. healthcare system,” Insight CEO Henry Pinchbeck said in a news release. “This investment allows us to accelerate our plan to enable every orthopedic surgeon in the U.S. to have easy access to personalized surgical devices within surgically meaningful timelines.”

Ross Morton, managing Partner at Nodenza, says Insight’s “disruptive” technology may enable the company to become “the leader in the personalized surgery market.”

The startup recently entered a strategic partnership with Ricoh USA, a provider of information management and digital services for businesses. It also has forged partnerships with the Hospital for Special Surgery in New York City, University of Chicago Medicine, University of Florida Health and UAB Medicine in Birmingham, Alabama.

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