Latest news with #preterminfants
Yahoo
5 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
02-07-2025
- Health
- Medscape
Fast Five Quiz: Probiotics Facts vs Fiction
Probiotics are undoubtedly a popular choice among many Americans. Consumers cite goals ranging from bowel health and regularity to vaginal health, bone density support, and immune boosts as reasons for using probiotic capsules, gummies, and beverages. However, confusion and concern from patients and healthcare providers persist over probiotic indications, quality, and reliability. How much do you know about probiotics and their applications? Test your knowledge with this quick quiz. Guidance from the AAP states that current evidence does not support the universal, routine administration of probiotics to preterm infants, especially those with birth weight < 1000 g. Despite some studies showing that probiotics reduce the risk of necrotizing enterocolitis in preterm infants or infants with very low birth weight, the AAP does not recommend their use due to conflicting data regarding safety and efficacy as well as the lack of pharmaceutical-grade, FDA-regulated probiotic products in the United States. Additionally, the AAP maintains no evidence of significant reduction of nosocomial sepsis in preterm infants is associated with probiotic supplementation. However, the American Gastroenterological Association (AGA) suggests using probiotics with specific combinations of bacterial species in infants < 37 weeks of gestational age and low birth weight to prevent necrotizing enterocolitis. Learn more about necrotizing enterocolitis. AGA clinical practice guidelines recommend probiotics in patients with C difficile infection only in the context of a clinical trial. Otherwise, the AGA makes no recommendations on the use of probiotics in C difficile colitis. A knowledge gap surrounds this topic as study data has been heterogenous. Learn more about C difficile colitis. Multiple organizations, such as the AGA and the World Gastroenterology Organisation (WGO), do not recommend probiotics for the management of Crohn's disease. According to the WGO, studies have not produced evidence that probiotics are beneficial for the remission or maintenance of remission of Crohn's disease. The AGA only recommends probiotics for Crohn's disease in the context of a clinical trial. Learn more about Crohn's disease. A meta-analysis of trials including a total of more than 1400 participants found that probiotic supplementation was associated with significant reductions in ALT, AST, and GGT in MASLD. Significant reductions in triglycerides, high-density lipoprotein and low-density lipoprotein cholesterols, insulin, insulin resistance, tumor necrosis factor alpha, BMI, and C-reactive protein were also observed with probiotic supplementation. A separate meta-analysis including more than 5100 participants on the effects of probiotics on ALT, AST, and GGT in patients with MASLD also found reductions in all three liver enzymes associated with probiotic use. Learn more about MASLD. Per the International Scientific Association for Probiotics and Prebiotics, probiotics are defined as 'live microorganisms that, when administered in adequate amounts, confer a health benefit.' Probiotics are found in foods such as kimchi, yogurt (with live and active cultures), and certain cheeses. Prebiotics are typically fiber or other complex carbohydrates that function as metabolic food for beneficial microorganisms. Some examples of prebiotic-containing foods include flaxseeds, whole oats, and barley. Prebiotics and probiotics might both be used to treat conditions as well as for disease prevention. Some fermented foods, like miso and sauerkraut, contain live strains of probiotics. Prebiotics are bioactive compounds found in fiber-rich foods, such as whole grains, and undergo fermentation by bacteria in the gut. Probiotics might be found in solid foods, supplement beverages, as well as supplement capsules and gummies. Prebiotics are present in fiber-rich foods and are also available as purchasable supplements. Learn more about about fiber supplementation.
