TUCSON, Ariz., February 15, 2023 — Critical Path Institute (C-Path) today announced that Airway Therapeutics, Inc. (“Airway”) has become a member of its International Neonatal Consortium (INC). Airway 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.
Airway is advancing the novel recombinant human protein rhSP-D — an engineered version of the endogenous protein hSP-D — that reduces inflammation and infection while modulating the immune response.
The company’s initial focus has been on a serious respiratory disease called bronchopulmonary dysplasia (BPD), which affects very preterm infants causing short-and long-term lung damage. The disease can lead to pro-longed NICU stays, as well as a range of co-morbidities and even death. Airway is committed to preventing and treating BPD by advancing a new biologic called zelpultide alfta (AT-100). A Phase 1b clinical trial to confirm the feasibility of intratracheal administrations of zelpultide alfa and its beneficial safety and tolerability profile ongoing and expected to end in June of this year.
“Airway’s research in BPD is not only encouraging, but so important to neonate population; we are thrilled to welcome them as members of C-Path’s pediatrics consortium, INC,” said INC Executive Director Kanwaljit Singh, M.D., M.P.H. “INC’s diverse stakeholders and members are dedicated to bringing life-altering treatments and approaches in neonatal care.”
INC accelerates the development of safe and effective therapies for neonates. The consortium engages the global neonatal community — families, neonatal nurses, academic scientists, regulators, pharmaceutical investigators, advocacy organizations and funders — to focus on the needs of the neonate. Through teams that share data, knowledge and expertise, INC advances medical innovation and regulatory science for this underserved population. To learn more about INC, visit c-path.org/inc or contact us at incinfo@c-path.org.
Airway Therapeutics, Inc. 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. Their current randomized, blinded Phase 1b study of zelpultide alfa is currently enrolling very prematurely born infants requiring mechanical ventilation. The clinical trial will confirm the feasibility of intratracheal administration of zelpultide alfa in a randomized dose escalation study designed to evaluate the safety and tolerability in 36 patients. Airway anticipates preliminary data from its Phase 1 b study in 2Q2023. For more information about the trial, refer to the clinicaltrials.gov identifier: NCT04662151.
Zelpultide alfa is Airway’s first candidate in development for prevention of BPD in very preterm infants. Concurrently, Airway is conducting a Phase 1b study for treatment of seriously ill patients with community acquired pneumonia including COVID-19, requiring mechanical ventilation. To learn more, visit https://www.airwaytherapeutics.com.
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. Operates from Dublin, Ireland with additional staff in multiple other locations. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
Contact:
Kissy Black
C-Path
615.310.1894
kblack@c-path.org
