Airway Therapeutics Announces First Patient Dosed in Phase 1b Trial of AT-100 in Preterm Infants at Risk for Bronchopulmonary Dysplasia (BPD)
PR95268
MARIETTA, Ga., March 31, 2022 /PRNewswire=KYODO JBN/ --
-- Novel preventative AT-100 offers potential to reduce incidence and severity
of serious respiratory disease BPD, improving outcomes in very preterm infants
Airway Therapeutics (https://c212.net/c/link/?t=0&l=en&o=3489603-1&h=4231491452&u=https%3A%2F%2Fwww.airwaytherapeutics.com%2F&a=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
March 28, 2022 in the Phase 1b randomized trial of AT-100 (rhSP-D) for
preventative use in very preterm infants at risk for bronchopulmonary dysplasia
(BPD). The clinical trial will confirm the feasibility of intratracheal
administrations of AT-100 and its beneficial safety and tolerability profile.
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Very preterm infants whose lungs are not fully developed must be intubated and
ventilated to enable breathing. Although the mechanical ventilation and oxygen
support preserves life, it damages delicate lung tissue, causing inflammation
and infection which can result in scarring and susceptibility to infections and
chronic disease, including BPD for which 2.5 million very preterm infants are
at risk globally each year.
"Though mechanical ventilation is necessary for sustaining life in most very
preterm infants, the resulting inflammation, lung damage and arrest of lung
development increase risk for BPD, for which there are currently no approved
treatments," said Marc Salzberg, M.D., CEO of Airway Therapeutics. "We are
excited to initiate evaluation of AT-100 as a preventative treatment option to
reduce the incidence, severity and consequences of BPD in very prematurely born
infants to improve patient outcomes and provide hope to patients' families."
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. In preclinical studies, AT-100
has shown to reduce inflammation and infection triggered by mechanical
ventilation and oxygen support, and ultimately reduce the onset of lung damage.
"Development of BPD can result in lifelong consequences for affected infants
and their caretakers including asthma, recurrent pneumonia as well as growth
and developmental problems," said Brenda Poindexter, M.D., M.S., Chief of
Neonatology, System Medical Director for Neonatology and Professor of
Pediatrics at Children's Healthcare of Atlanta and Emory University.
"Preclinical data suggest that AT-100 holds promise to become the first
globally available commercial product for prevention of BPD, enhancing outcomes
beyond the current standard of care."
The Phase 1b trial is currently enrolling very prematurely born infants
requiring intubation and mechanical ventilation. The randomized dose escalation
study is designed to evaluate the safety and tolerability of AT-100 in 36
patients as compared to air-sham procedures alone. Airway anticipates data in
1Q2023. The Phase 1b trial will be followed by a randomized Phase 3 trial with
preliminary results expected as soon as 2Q2024. For more information about the
trial, refer to the www.clinicaltrials.gov identifier: NCT04662151
Concurrently, AT-100 is also being evaluated for therapeutic use in severely
ill COVID-19 patients requiring intubation and mechanical ventilation in an
ongoing Phase 1b trial (NCT04659122(https://c212.net/c/link/?t=0&l=en&o=3489603-1&h=2929251015&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04659122%3Fterm%3DAirway%2BTherapeutics%26draw%3D2%26rank%3D1&a=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 Therapeutics
Airway 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.
SOURCE: Airway Therapeutics, Inc.
CONTACT: Meghan Riley, riley@airwaytherapeutics.com
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