An Ohio-based biotech continues to work “around the clock” to advance its protein replacement therapy as a potential treatment for the novel coronavirus – including a new collaboration with a European-based manufacturer to boost supply, while also taking the first steps toward clinical trials with the Food & Drug Administration.
Airway Therapeutics has been advancing AT-100, or rhSP-D, an engineered version of a protein, hSP-D, that reduces inflammation and infection in the body, for the prevention of bronchopulmonary dysplasia, or BPD, a ventilation-induced respiratory illness, in very preterm infants. But, given AT-100’s anti-inflammatory and anti-infective properties, the company says it’s a potential treatment option for the COVID-19 virus, as well as respiratory diseases like influenza and RSV, as well.
Marc Salzberg, M.D., president and chief executive officer of Airway Therapeutics, said hSP-D plays the role of “immune police” in the lung. When there’s a virus or infection, or if mechanical ventilation is used, and the lung is damaged, that protein level is reduced. The lung cells have a hard time producing more, “during a moment when it’s needed most.”
“Our concept is: We need to add that protein back because it’s a natural protein, likely well tolerated, but the big challenge was, it’s a complex, complicated protein in the way it’s shaped,” Salzberg said. “We’ve developed a manufacturing process and now have a human grade protein that we can use in patients.”
AT-100 is a potential therapy for the novel coronavirus because it targets critical stages of viral infection in many ways. AT-100, in the presence of COVID cells, binds to the virus’ spike protein, preventing further replication. AT-100 forms aggregates, which are then recognized by immune cells, and cleared away.
New data, Salzberg said, shows that AT-100 also inhibits the production of mucus in the lung; mucus makes it difficult for patients, with very serious illness, to be intubated and ventilated.
“There’s no other drug – existing or new – that comes even close to the combination of all these properties in one,” Salzberg said. “That’s groundbreaking. And overall, from a safety probability perspective, it’s a copy of the human protein, suggesting that there’s not really major toxicities expected. And if you follow the therapies being testing for COVID, toxicity is becoming an issue more and more.”
Last week, the company announced a collaboration with Celonic Group, a biologic manufacturer based in Basel, Switzerland, to produce AT-100. Airway Therapeutics currently has a batch of AT-100 in production in the U.S. for its study with pre-term born babies, but it’s not at the scale needed for a COVID-19 trial. The production process for AT-100 is “very complex,” Salzberg said. But the tech transfer is now complete and production is expected to begin June 15.
“AT-100…has never been produced for larger-scale clinical trial indications. We needed to find a manufacturer that’s capable of handling that quickly, and Celonic is actually very well-versed with the technology that we’re using for production,” he said.
Airway Therapeutics on Friday also submitted a pre-IND, or pre-investigational new drug application, to the FDA to pursue AT-100 as a treatment for the COVID-19 virus. The FDA is accelerating the review process for COVID-related therapies, and Salzberg expects to receive feedback on the proposal in a matter of days. Airway will then submit a full IND package. He’s hoping for FDA approval by early fall, in conjunction with an expected second wave of COVID-19 cases.
“On one hand, [AT-100] is for sure a bridge until there’s a vaccine. But I believe AT-100 will have spot in the management of COVID no matter what,” Salzberg said. “The common opinion is, once we have a vaccine, the whole thing goes away. The chance that there’s a vaccine and it will protect everybody 100 percent is, in my opinion, very, very unlikely. The influenza vaccine protects 50-60 percent. Hopefully there will be a vaccine, but that will [only] be one of the elements for treatment. AT-100 is a very promising element in the management of these patients.”
Airway Therapeutics, created in 2011 as a spinout of Cincinnati Children’s Hospital Medical Center, the nation’s third-ranked pediatric facility, closed a $15.5 million Series C in January. Salzberg said the company has raised an additional $4 million within the last few weeks in order to continue its COVID-19 pursuits. The company could make a good IPO candidate, he said. He declined to give a timeline, but if Airway did pursue that pathway, it would happen “in the not so distant future.”
The company has been working for months on advancing AT-100 as a treatment option for COVID-19 patients, and in March, filed with the respiratory diseases branch of the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), to further speed up that process.
“If AT-100 was being developed by one of the major pharmaceutical companies, it would be all over place in the media,” Salzberg said. “We’re getting much more traction now, but we’re a small biotech, so we need to find our own way. For COVID, it’s about getting the funds as quickly as possible to be able to help. “