– Novel therapeutic AT-100 offers potential to reduce inflammation, associated injury and incidence of secondary infection, and inhibit viral replication and promote viral elimination in severely ill, mechanically-ventilated COVID-19 patients

Initial data readout anticipated in Q4 2021

CINCINNATI, Aug. 26, 2021 /PRNewswire/ — Airway Therapeutics, Inc. (Airway), a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, announced dosing of the first patient on August 17, 2021 in the AT-100 (rhSP-D) Phase 1b trial in mechanically-ventilated COVID-19 patients. The clinical trial will confirm the feasibility of intratracheal administrations of AT-100 and its safety and tolerability.

“As a novel therapeutic candidate, AT-100 has the potential to treat severely ill COVID-19 patients, and this clinical trial comes at an important point in the management of these desperate patients,” said Marc Salzberg, M.D., CEO of Airway Therapeutics. “COVID-19 is the first of several conditions for which AT-100 will be evaluated, and we are eager to advance this clinical trial for patients in need as a potential new weapon against the disease.”

Airway’s AT-100 is a recombinant version of the endogenous human SP-D, a protein essential to the lung’s immune defense, designed to reduce inflammation and infection while modulating immune responses across a breadth of respiratory diseases inside and outside the lung. In preclinical studies, AT-100 has shown potential to inhibit SARS-CoV-2 replication and promote viral elimination. Additionally, AT-100 offers the potential to decrease risk of secondary infections in severely ill, intubated COVID-19 patients. This multifaceted mechanism of action makes AT-100 a differentiated and promising therapeutic for COVID-19.

“As the coronavirus pandemic continues to evolve, we are observing severe COVID-19 infections amongst a broader demographic of the U.S. population,” said R. Duncan Hite, M.D., Mark & Alice Brown Professor of Internal Medicine at the University of Cincinnati, Medical Director of the Medical Intensive Care Unit (MICU) at UC Medical Center, and Principal Investigator of the AT-100 trial. “There is an immediate and urgent need for viable treatments that deliver improved patient outcomes, particularly in patients with severe disease.  Initiation of the AT-100 clinical trial has proven to be very timely for the latest surge of infections. Given the dual potential for AT-100 to directly impact viral clearance and reduce lung inflammation, we are hopeful that it proves to be an additional treatment option for the unfortunate patients battling severe COVID-19 who are at highest risk for prolonged hospital stays and death.”

The Phase 1 trial is currently enrolling hospitalized adults requiring intubation and mechanical ventilation. The dose escalation study is designed to evaluate the safety and tolerability of AT-100 and the feasibility of intratracheal administration for up to 7 doses in 9 patients. Airway anticipates early data in Q4 2021. For more information about the trial, refer to the clinicaltrials.gov identifier: NCT04659122.

About AT-100 AT-100 (rhSP-D) is a novel recombinant version of the endogenous human protein hSP-D, a protein that reduces inflammation and infection in the body while modulating the immune response to break the cycle of injury and inflammation. Airway is focused on advancing AT-100 for the prevention of BPD in very preterm born babies and as a therapeutic for seriously ill COVID-19 patients. AT-100’s anti-inflammatory and anti-infective properties also make it a potential treatment for other respiratory diseases such as influenza, respiratory syncytial virus (RSV) and inflammatory diseases outside the lung. The FDA and European Medicines Agency have granted AT-100 Orphan Drug Designation.

About Airway TherapeuticsAirway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing the novel recombinant human protein hSP-D, a version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response. AT-100 is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID-19 in seriously ill mechanically ventilated patients. To learn more, visit https://www.airwaytherapeutics.com.

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