GA-AIRWAY-THERAPEUTICS
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, announced today it received the Whitsett Award for highest scoring abstracts from the Neonatal and Developing Lung Executive Committee at the American Thoracic Society (ATS) 2024 International Conference.
The abstract is titled “Randomized Blinded Phase 1b Study Demonstrates Safety and Tolerability of Zelpultide Alfa (rhSP-D) in Preterm Neonates at High Risk for the Development of Bronchopulmonary Dysplasia (BPD).” Thirty-seven infants, born at 23 weeks to 28 weeks and 6 days, were enrolled in the study in the US and Europe. No dose limiting toxicities were found while indications of efficacy were observed.
As many as 2.5 million very preterm infants globally are at risk of developing BPD from lung damage caused by mechanical ventilation and oxygen support. Babies who develop BPD can suffer lifelong complications such as asthma and pneumonia as well as growth and developmental problems.
The Whitsett Award is named for Jeffrey A. Whitsett, M.D., Director of the Section of Neonatology, Perinatal and Pulmonary Biology at Cincinnati Children's Hospital Medical Center. Raquel Arroyo, Ph.D., PharmD, Airway’s Director of Clinical Sciences, accepted the award as lead author of the abstract.
“We are grateful to the parents of these fragile patients participating in the first clinical study with zelpultide alfa in very preterm neonates, and also thank the investigators and their study teams for their participation,” said Airway CEO and Chief Medical Officer Marc Salzberg, M.D. “Dr. Arroyo proudly received the Whitsett award on behalf of the investigators and in recognition of her invaluable contribution to the development of zelpultide alfa. Based on the successful completion of the Phase 1b study we plan to launch a pivotal multinational trial in Q4/2024 enrolling more than 300 neonates born at 23 weeks to 27 weeks and 6 days.”
The pivotal trial, which will begin in Spain and Italy, will be a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy of zelpultide alfa (administered intratracheally) in preventing BPD compared to standard of care plus air-sham (intratracheal administration of room air).
Zelpultide alfa is a recombinant version of the endogenous human SP-D, a protein essential to the lung’s immune defense in reducing inflammation and infection while modulating immune responses. The biologic is administered intratracheally during mechanical ventilation. The FDA and European Medicines Agency have granted orphan drug status to zelpultide alfa.
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 zelpultide alfa, a novel recombinant human protein hSP-D that reduces inflammation and infection in the body while modulating the immune response. Zelpultide alfa is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID/CAP in seriously ill mechanically ventilated patients.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240624070940/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Daiichi Sankyo Announces the Initiation of the Development of Oral Triple Combination Lipid-Lowering Tablets to Support the Management of LDL-C30.8.2025 18:00:00 CEST | Press release
Initiation of the development of new oral triple combination tablets, aimed at improving adherence and outcomes in low-density lipoprotein cholesterol (LDL-C) management. Recent findings from MILOS and SANTORINI registries presented at ESC Congress 2025, highlight ongoing challenges in accurately assessing cardiovascular (CV) risk and helping patients reach LDL-C targets.1-5 Furthermore, data from a four-country cohort of the MILOS study support the real-world effectiveness and safety of bempedoic acid in both sexes.6 Simulation using SANTORINI data reveals the potential of improved LDL-C goal attainment with tailored oral combination therapy of statins, ezetimibe and bempedoic acid, in line with the latest 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias.7,8 Daiichi Sankyo has a long-standing commitment to easing treatment of cardiovascular disease (CVD) and exploring new treatment options that improve CVD outcomes and treatment adherence. Daiich
Alnylam to Advance Zilebesiran into Global Phase 3 Cardiovascular Outcomes Trial30.8.2025 16:30:00 CEST | Press release
- Phase 3 Trial Informed by KARDIA-3 Phase 2 Study Results Presented as a Late-Breaking Abstract at the European Society of Cardiology Congress 2025 -- Zilebesiran Demonstrated Clinically Meaningful Reductions in Office Systolic Blood Pressure in Patients with Uncontrolled Hypertension and High Cardiovascular Risk at Month 3 Primary Endpoint, with Continuous Control Through Month 6 -- Zilebesiran Displayed Encouraging Safety When Combined with Two or More Antihypertensives -- Results Support Biannual Dosing Regimen and Inform Phase 3 Trial Design: Trial Expected to Initiate by Year-End 2025 -- Alnylam to Host Webcast Investor Event on August 30, 2025, at 1:00 pm ET (7:00 pm CEST) - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced plans to initiate a Phase 3 cardiovascular outcomes trial (CVOT) to evaluate the potential of zilebesiran to reduce the risk of major adverse cardiovascular events. This decision is informed by results from t
Andersen Consulting styrker sine kompetencer inden for virksomhedstransformation med Fabric29.8.2025 17:01:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform gennem en samarbejdsaftale med Fabric, der er et strategisk designfirma, der arbejder med organisationer for at integrere bæredygtighed, forsyningskæder og menneske-centreret innovation på tværs af kultur og drift. Fabric blev grundlagt i Japan i 2021 og arbejder sammen med virksomheder og globale brands om at skabe regenerative forretningsmodeller sammen samt bæredygtige brandstrategier og fremtidssikrede produkter. Ved hjælp af strategiske designmetoder og designfilosofi skaber virksomheden indsigtsbaseret transformation på tværs af forsyningskæder, brand og HR. Fabric er kendt for sin systemtænkning og sit engagement i social og miljømæssig bæredygtighed og fremmer desuden digitale transformationsinitiativer, der integrerer bæredygtighed, humankapital og AI. "Fabric er skabt for at hjælpe virksomheder med at blomstre gennem regenerative relationer til mennesker, samfund og forbundne, levende systemer," sagde James Hollow, der er grundlægger a
Andersen Consulting tilføjer samarbejdsfirmaet Skribble29.8.2025 16:28:00 CEST | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for strategi og virksomhedstransformation gennem en samarbejdsaftale med Skribble, der er et rådgivningsfirma inden for digital teknologi og branding, der hjælper virksomheder i Sydøstasien med innovation og driftsmæssig transformation. Skribble, der blev etableret i 2020, tilbyder en bred vifte af services, herunder brand- og kommunikationsstrategi, digital markedsføring, specialudvikling af teknologi, forandringsledelse og platformsløsninger. Virksomheden hjælper organisationer inden for ejendomme, forbrugsvarer, bankverdenen og den offentlige sektor ved at sikre, at strategi og eksekvering er tæt forbundet – med henblik på at levere integrerede løsninger inden for brand, performance og teknologi. Skribbe fokuserer på procesoptimering har kreative og tekniske kompetencer, der hjælper kunderne med at skabe forandringer og vækst. "Hos Skribble arbejder vi på at omsætte kreativ energi til strategiske resultater," sagde Chan Leong, CEO f
BeOne Medicines Announces Positive Topline Results for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma (MCL)29.8.2025 12:00:00 CEST | Press release
Study met its primary endpoint of overall response rate (ORR), demonstrating clinically meaningful responses in rare B-cell lymphoma with high unmet needBeOne to submit data to global regulatory authorities for their review and potential approval BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. BeOne plans to present the full data at an upcoming medical meeting. “For people with relapsed or refractory mantle cell lymphoma, the disease is aggressive, the treatment landscape fragmented, and the outcomes unacceptably poor. These topline results for sonrotoclax underscore its potential to deliver meaningful and
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom