Airway Therapeutics Announces FDA Acceptance of IND for AT-100 in Preterm Infants at Risk for Bronchopulmonary Dysplasia (BPD)
PR88703
CINCINNATI, March 26, 2021 /PRNewswire=KYODO JBN/ --
-- Initiating Phase 1b randomized clinical trial with initial results expected
in late 2021
-- Potential for novel, preventive AT-100 to reduce incidence and severity of
serious respiratory disease BPD, improving outcomes and survival in very
preterm infants
Airway Therapeutics (
), Inc., a biopharmaceutical company developing a new class of biologics to
break the cycle of injury and inflammation for patients with respiratory and
inflammatory diseases, today announced the U.S. Food and Drug Administration
(FDA) has accepted its Investigational New Drug (IND) application to develop
AT-100 (rhSP-D) as a preventive treatment for the serious respiratory disease
BPD in very preterm babies.
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Airway will initiate a Phase 1b randomized clinical trial to confirm the
feasibility of intra-tracheal administration of AT-100 and its beneficial
safety and tolerability profile. The Phase 1b trial will be followed by a
randomized pivotal trial with preliminary results expected as soon as second
half 2023.
"Preterm infants with BPD have higher mortality, and those who survive suffer
from lifelong chronic consequences. With no approved treatments for BPD, AT-100
has potential to reduce incidence and severity of BPD, related short- and
long-term consequences, and ultimately improve the survival of these vulnerable
patients," said Marc Salzberg, M.D., CEO of Airway. "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."
AT-100 is a novel human recombinant protein – an engineered version of an
endogenous protein -- that has been shown in preclinical studies to reduce
inflammation and infection triggered in very preterm babies, by mechanical
ventilation and oxygen support, and ultimately reduce the onset of lung damage.
Very preterm infants whose lungs are not fully developed must be intubated and
ventilated to enable breathing. Although the mechanical ventilation preserves
life, it can damage fragile lung tissue, causing inflammation and infection
which can result in the arrest of lung development, and ultimately BPD.
Airway has filed an additional IND application with the FDA for AT-100 for
treatment of COVID-19. In addition to its anti-inflammatory properties,
preclinical studies of AT-100 have shown potential to inhibit SARS-CoV-2
replication and promote viral elimination. AT-100 may also reduce secondary
infections in mechanically ventilated COVID-19 patients. This multidimensional
approach differentiates AT-100 from other COVID-19 treatments in development.
About AT-100
AT-100 is a novel recombinant human protein rhSP-D, an engineered version of an
endogenous 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
rhSP-D, an engineered 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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