Airway Therapeutics, a Sharonville-based biopharmaceutical startup, has logged another key milestone in its path toward commercialization. The company, which is developing new interventions for acute and chronic lung diseases, dosed its first patient this month in a new clinical trial aimed at patients severely impacted by Covid-19.
The accomplishment is a huge step for the company, CEO Dr. Marc Salzberg told me, and comes as infections from the virus increase nationwide. It serves as a new potential treatment option for patients in desperate need, he said.
The phase 1b trial is evaluating AT-100, also known as rhSP-D, an engineered version of a protein that reduces inflammation and infection in the body, in the treatment of severe Covid-19 patients — those mechanically-ventilated and intubated.
In Covid-19 patients, Airway said AT-100 has the potential to:
- reduce inflammation, and ultimately, associated injury from being intubated and ventilated.
- reduce the rate of secondary infection.
- inhibit viral replication.
- promote viral elimination in severely ill, mechanically-ventilated Covid-19 patients.
The U.S. Food and Drug Administration and European Medicines Agency granted AT-100 orphan drug designation earlier this year.
The clinical trial will confirm the feasibility of intratracheal administrations of AT-100 and its safety and tolerability.
Patients are participating in the study at the University of Cincinnati led by principal investigator Dr. Duncan Hite. The first patient was dosed Aug. 17 at UC Medical Center.
The first patient, Salzberg said, is much improved. The patient has since been extubated since treatment was administered. In total, Airway wants to enroll nine patients.
Initial data is expected in the fourth quarter.
“Given the caution that I need to [exercise] both as a scientist and as a physician, it’s exciting,” Salzberg said. “We’re very optimistic.”
The initiation of the AT-100 clinical trial has “proven to be very timely,” said Hite, who, besides serving as the trial’s principal investigator, is director of the medical ICU at UC Medical Center and a professor of internal medicine at the University of Cincinnati.
Hospitals nationwide are experiencing a new surge of Covid-19 infections, and Hite said they are observing severe Covid-19 infections across a broader demographic of the U.S. population.
“There is an immediate and urgent need for viable treatments that deliver improved patient outcomes, particularly in patients with severe disease,” he said in a release. “Given the dual potential for AT-100 to directly impact viral clearance and reduce lung inflammation, we are hopeful it proves to be an additional treatment option for patients at highest risk for prolonged hospital stays and death.”
Airway Therapeutics, created in 2011 as a spinout of Cincinnati Children’s Hospital, has largely been advancing AT-100 for the prevention of bronchopulmonary dysplasia, or BPD, in very preterm infants, a condition for which there is currently no approved treatment.
About 160,000 preterm babies in the United States and Europe are at risk each year for BPD, and nearly half die. Those who survive suffer from lifelong medical problems, and management of BPD costs an estimated $2 billion annually in the U.S. alone, Airway stated.
AT-100’s anti-inflammatory and anti-infective properties also make it a potential treatment for Covid-19.
In a previous interview, Salzberg told me his team was “working around the clock” to advance AT-100 as a possible solution for Covid, given its impact on public health.
“The expectation is Covid will not dissipate anytime soon,” he said. “We’re happy we might have something that could help."
Salzberg said Airway Therapeutics will be exploring another round of investment over the next six months. The company is one of the region’s best-funded startups, and its last round, a Series C, drew $15.5 million in January 2020.
After that, Airway has various options. The company is generating interest from pharmaceutical companies, and Salzberg did not rule out a potential IPO. The right path will be the one that ensures the long-term success of the company and the development of AT-100, he said.
“We’re at a crossroads,” Salzberg said. “The interest triggered from investors and pharmaceutical companies [with our FDA approval] was already big, and now that we've started to treat patients, interest is spiking even more. We in a very interesting position.”
