A Greater Cincinnati biopharma startup that’s developing new interventions for acute and chronic lung diseases – including for very preterm infants and Covid-19 patients – received a key U.S. Food and Drug Administration approval last week.
Sharonville’s Airway Therapeutics said Friday the FDA accepted the company's investigational new drug application to develop its protein replacement therapy, known as AT-100, as a preventive treatment for BPD, a serious respiratory disease in very preterm babies.
It represents a key milestone for the company, officials said, as Airway looks ahead to pivotal clinical trials, typically the last regulatory step before commercialization.
AT-100 is a novel recombinant human protein rhSP-D – or an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response to break the injury cycle of inflammation.
Very preterm infants whose lungs are not fully developed must be intubated and ventilated. Although the mechanical ventilation preserves life, it can damage lung tissue, causing inflammation and infection which can result in the arrest of lung development, and ultimately BPD.
Currently, there are no approved treatments for BPD. As many as 160,000 preterm babies are at high risk to develop BPD each year in the U.S. and Europe, Airway said. Babies with BPD have higher mortality, and those that survive suffer from lifelong chronic consequences. Management of the disease costs an estimated $2 billion annually in the U.S. alone.
“We are excited to advance this new therapy into the clinic with the potential to deliver novel therapies for patients in desperate need of new treatment options,” Dr. Marc Salzberg, CEO of Airway, said in the release.
Airway, in a release, said it will initiate a Phase 1b clinical trial to confirm the feasibility of intratracheal administration of AT-100 and its beneficial safety and tolerability. The Phase 1b trial will be followed by a pivotal trial with preliminary results expected as soon as second half 2023.
Airway has also filed an additional investigational new drug application with the FDA to use AT-100 as a treatment for Covid-19. In addition to its anti-inflammatory properties, preclinical studies have shown its potential to inhibit virus replication and promote viral elimination. AT-100 may also reduce secondary infections in ventilated Covid-19 patients. This differentiates AT-100 from other Covid-19 treatments in development, the company said.
Airway Therapeutics was created in 2011 as a spinout of Cincinnati Children’s Hospital Medical Center, the nation’s third-ranked pediatric facility, and is one of the region’s most well-funded startups. Its last round, a Series C, drew $15.5 million in January 2020. Investors weren’t disclosed, but its previous backers have included Cincinnati Children’s, Cincy Tech and Queen City Angels, as well as Danmar Capital, a Los Angeles-based venture capital firm.
