Latest news with #bronchopulmonarydysplasia
Yahoo
6 days ago
- Business
- Yahoo
Airway Therapeutics Receives European Medicines Agency Pediatric Committee Approval for Zelpultide Alfa's Study Plan in Bronchopulmonary Dysplasia for Very Preterm Infants
Multinational Phase 2b dose selection and Phase 3 expansion study for zelpultide alfa set to begin in late Q3/Q4 2025 MARIETTA, Ga., Aug. 12, 2025 /CNW/ -- Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious diseases, today announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved its Pediatric Investigation Plan (PIP) for its investigational biologic, zelpultide alfa, in its initial indication for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks gestational age. Zelpultide alfa is a first-in-class recombinant human surfactant protein D (rhSP-D) designed to modulate immune responses to reduce inflammation, enhance pathogen clearance, and support surfactant homeostasis for improved lung function. "We are pleased to have reached agreement with the PDCO on the Pediatric Investigation Plan and pivotal study design for zelpultide alfa, a ground-breaking therapy being developed to prevent BPD in very preterm infants, a highly vulnerable population with no approved preventative treatments," said Dr. Marc Salzberg, Chairman, Chief Executive & Medical Officer of Airway Therapeutics. "This marks a significant milestone in advancing a potential first-in-class preventive therapy to improve outcomes for these fragile infants and address a critical unmet medical need." The approved PIP includes the design and execution plan for a pivotal Phase 2b/3 clinical trial. The Phase 2b trial will evaluate two different dose levels of zelpultide alfa administered for up to seven days, compared to placebo. Following completion of treatment in 150 patients (50 per arm), one dose will be selected for continuation into Phase 3, during which approximately 216 additional patients will be enrolled. As part of the study, Airway Therapeutics will assess a three-day consecutive BPD evaluation endpoint, which may contribute to the development of improved outcome measures during the studies. "Bronchopulmonary dysplasia remains one of the most challenging complications in neonatal intensive care, with long-term consequences for respiratory and neurodevelopmental outcomes," said Dr. Daniele De Luca, Principal Investigator of the trial and Professor of Pediatrics (Neonatology) at Paris Saclay University. "Zelpultide alfa represents a novel and scientifically promising approach, grounded in our understanding of immune modulation and tissue injury. This study will allow us to rigorously evaluate its potential to change clinical practice by addressing the root drivers of lung injury in very preterm infants." Airway Therapeutics plans to submit the PDCO-approved protocol immediately to health authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH), with the objective of initiating the clinical trial in these countries in late Q3 or Q4 2025. Additional submissions will follow in France, Germany, Belgium, and Poland, along with planned regulatory filings in Argentina, Australia, and the United States. About Zelpultide Alfa Zelpultide alfa is a recombinant human surfactant protein D (rhSP-D) precisely engineered to replicate the native protein's full quaternary structure and biological function, incorporating optimized glycosylation through advanced cell line technology. Its therapeutic activity is driven by three key mechanisms: modulation of immune responses to mitigate excessive inflammation, enhancement of pathogen recognition and clearance, and maintenance of surfactant homeostasis to support pulmonary function. As a versatile biologic platform, zelpultide alfa is being developed for patients across all age groups—from preventing bronchopulmonary dysplasia (BPD) in very preterm infants to treating acute and chronic respiratory, inflammatory and infectious conditions in adults. Zelpultide alfa's lead indication, BPD prevention, is currently progressing through a pivotal Phase 2b/3 clinical trial, following Phase 1 study that demonstrated a favorable safety and tolerability profile. About Airway Therapeutics Airway Therapeutics is a clinical-stage biopharmaceutical company developing a new class of biologic therapies to redefine the prevention and treatment of respiratory, inflammatory, and infectious diseases. Its lead candidate, zelpultide alfa, is currently in late-stage clinical development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants, a condition with no approved preventive therapies. As a platform biologic, zelpultide alfa is also being advanced for broader application across age groups and disease settings, with the goal of improving outcomes for vulnerable patient populations. For more information, please visit Company Contact:Libba MuziAirway Therapeuticsmuzi@ Media Contact:Tony Russo, Ph.D. Russo Partners, View original content to download multimedia: SOURCE Airway Therapeutics View original content to download multimedia:
Medscape
21-07-2025
- Health
- Medscape
NIPPV Outperforms NCPAP in Premature Infant Lung Care
TOPLINE: Nasal intermittent positive pressure ventilation (NIPPV) reduced the risk of requiring invasive ventilation and developing bronchopulmonary dysplasia by nearly half compared with nasal continuous positive airway pressure (NCPAP) in premature infants with respiratory distress syndrome. METHODOLOGY: Researchers conducted an updated meta-analysis of 14 randomized trials involving 1755 premature infants (< 37 weeks' gestation) with respiratory distress syndrome to compare NIPPV with NCPAP as their initial respiratory support. Data were gathered through systematic searches of Medline, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials for studies published between 1980 and February 2022. Primary outcomes were the incidence of invasive ventilation and bronchopulmonary dysplasia. Subgroup analyses were stratified by — infants who received surfactant treatment, gestational age (> 30 or ≤ 30 weeks), and birth weight (> or ≤ 1500 g). Secondary outcomes included mortality, pulmonary air leaks, retinopathy of prematurity stage ≥ 2, necrotizing enterocolitis Bell stage ≥ 2, and intraventricular hemorrhage grade ≥ 3. TAKEAWAY: NIPPV demonstrated superior efficacy with a 47% reduction in the incidence of invasive ventilation requirement (relative risk [RR], 0.53; P < .001) and a 49% reduction in the incidence of bronchopulmonary dysplasia (RR, 0.48; P = .004) compared with NCPAP. Benefits of NIPPV on invasive ventilation incidence persisted across subgroups defined by gestational age, birth weight, and surfactant treatment. However, reductions in bronchopulmonary dysplasia were significant only when stratified by gestational age. Secondary outcomes showed no significant differences between groups. No increase in pneumothorax was observed with NIPPV. IN PRACTICE: 'While these findings are promising, higher-quality randomized controlled trials with standardized protocols are needed before definitive clinical recommendations can be established,' the authors of the study wrote. SOURCE: This study was led by Juan Zeng, Southwest Hospital of Army Medical University, and Rong Tan, Jiulongpo People's Hospital, both in Chongqing, China. It was published online on June 28, 2025, in the European Journal of Pediatrics. LIMITATIONS: Although synchronized NIPPV may offer advantages over nonsynchronized NIPPV, insufficient data prevented subgroup comparisons of the two modes. As most trials enrolled infants with gestational age > 30 weeks, the findings may not be generalizable to extremely premature neonates. Finally, the overall low methodological quality and limited number of robust, high-quality studies reduce confidence in these conclusions. DISCLOSURES: The authors declared that they did not receive any funds, grants, or other support. The authors declared having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
02-07-2025
- Health
- Medscape
Glucose Monitoring Shows Dysglycaemia in Premature Infants
TOPLINE: In very low birth weight (VLBW) infants, continuous glucose monitoring (CGM) at 36 weeks of postmenstrual age (PMA) revealed subclinical dysglycaemia; male infants showed prolonged hyperglycaemia, and prior insulin therapy predicted extended hypoglycaemia. METHODOLOGY: Researchers evaluated the prevalence of dysglycaemia in VLBW infants at 36 weeks of PMA through CGM and investigated associated risk factors. The prospective cohort included 35 VLBW infants (mean gestational age, 27.3 weeks; 65.7% female infants; mean birth weight, 929 g) who were assessed at 36 weeks from 2016 to 2019. CGM was performed at 36 weeks of PMA using a blinded Dexcom G4 sensor for 48 hours, with dysglycaemia defined as glucose concentrations > 8 mmol/L (hyperglycaemia) or < 2.6 mmol/L (hypoglycaemia) sustained for at least 30 minutes. Researchers analysed risk factors (sex and prior insulin therapy) against capillary glucose correlations. TAKEAWAY: Overall, dysglycaemia was detected in 68.6% of infants; 28.6% of infants had hyperglycaemia alone, 17.1% had hypoglycaemia alone, and 22.9% had both. Male sex was linked to a longer duration of hyperglycaemia (B = 252.172; CI, 101.484-402.86; P = .002). Prior insulin treatment led to an increase in the duration of hypoglycaemia (B = 68.607; CI, 9.932-127.283; P = .023). Lower birth size and bronchopulmonary dysplasia were also associated with dysglycaemia. IN PRACTICE: "Male sex is associated with longer time spent in hyperglycemia and insulin treatment during the admission period is associated with longer time spent in hypoglycemia nearing term age. It is possible that these infants may require more rigorous monitoring of their glucose concentrations even when nearing term age," the authors wrote. SOURCE: This study was led by Itay Nilsson Zamir, Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden. It was published online on June 27, 2025, in the European Journal of Pediatrics. LIMITATIONS: The single-centre study design and small sample size may have limited generalisability. The CGM device used (Dexcom G4) had a higher-than-ideal mean absolute relative difference (18.8%). Calibrations relied on point-of-care glucometers rather than on laboratory-analysed values. DISCLOSURES: This study was supported by research grants from Umeå University and other sources. The CGM system was donated by Dexcom Inc., which had no role in the study design, data analysis, or publication. The authors declared having no competing interests. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
