A Greater Cincinnati biopharma startup that’s developing new interventions for acute and chronic lung diseases — including for very preterm infants — this week received another key U.S. Food and Drug Administration approval.
Sharonville’s Airway Therapeutics said Monday the FDA accepted the company's investigational new drug application to also develop its protein replacement therapy, known as AT-100, as a treatment for Covid-19.
It's the company’s second investigational new drug application approval in a month. The FDA March 26 accepted the company's investigational new drug application to AT-100 as a preventive treatment for BPD, a serious respiratory disease in very preterm babies.
Both are key milestones for the company, officials said. Airway is now initiating a Phase 1b clinical trial for AT-100 use in Covid-19 patients to confirm its feasibility, safety and tolerability.
"The pre-clinical data are encouraging and lead us to believe that AT-100 has therapeutic potential,” Dr. Marc Salzberg, CEO of Airway, said in the statement. "We are excited to advance the clinical development of AT-100 with the goal of delivering a novel therapy for severely ill COVID-19 patients who are in need of new treatment options."
AT-100 has been shown in preclinical studies to reduce inflammation and infection, ultimately preventing lung injury, a major concern for Covid-19 patients with respiratory conditions. Additionally, AT-100 has potential to inhibit replication of the virus and promote elimination. AT-100 may also reduce secondary infections in severe Covid-19 patients who are mechanically ventilated in ICUs.
This multidimensional approach “differentiates AT-100 from other Covid-19 treatments in development,” Airway said in a release.
Airway said it is leveraging the FDA's coronavirus treatment acceleration program aimed at evaluating new treatment options for Covid-19. In a previous interview, Salzberg told me his team is “working around the clock” to advance AT-100 as a possible solution for Covid, given its impact on public health. Initial trial results are expected in the third quarter of 2021.
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.
