Alveofact (bovactant) / Lyomark Pharma - LARVOL DELTA

APC-AF-CLN-003: Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome (clinicaltrials.gov) - P3 | N=520 | Not yet recruiting | Sponsor: Aerogen Pharma Limited | N=260 ➔ 520

Enrollment change • Acute Respiratory Distress Syndrome • Respiratory Diseases

APC-AF-CLN-003: Safety and Efficacy of AeroFact in Preterm Infants With Respiratory Distress Syndrome (clinicaltrials.gov) - P3 | N=260 | Not yet recruiting | Sponsor: Aerogen Pharma Limited | Trial completion date: Aug 2027 ➔ May 2029 | Initiation date: Apr 2025 ➔ Aug 2025 | Trial primary completion date: Aug 2026 ➔ May 2027

Trial completion date • Trial initiation date • Trial primary completion date • Acute Respiratory Distress Syndrome • Respiratory Diseases

Safety and Efficacy of AeroFact in Preterm Infants With Respiratory Distress Syndrome (clinicaltrials.gov) - P3 | N=260 | Not yet recruiting | Sponsor: Aerogen Pharma Limited

New P3 trial • Acute Respiratory Distress Syndrome • Respiratory Diseases

Comparative Biophysical Study of Clinical Surfactants using Constrained Drop Surfactometry. (PubMed, Am J Physiol Lung Cell Mol Physiol) - "At 10 mg/mL, Infasurf, Curosurf, and Survanta all demonstrated excellent dynamic surface activity, while Alveofact exhibited the poorest quasi-static and dynamic surface activity...Understanding the diverse biophysical behaviors of clinical surfactants provides crucial insights for precision and personalized design in treating RDS and other respiratory conditions. The findings from this study contribute valuable perspectives for development of more efficacious and fully synthetic surfactant preparations."

Journal • Acute Respiratory Distress Syndrome • Respiratory Diseases

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact (clinicaltrials.gov) - P2 | N=261 | Completed | Sponsor: Aerogen Pharma Limited | Active, not recruiting ➔ Completed

Trial completion • Acute Respiratory Distress Syndrome • Respiratory Diseases

Plasma Levels of Surfactant Protein D Support the Interpretation of Oxygenation Parameters in COVID-19 Patients With ARDS. (ATS 2024) - " We conducted an analysis on sequential daily plasma and tracheal aspirate samples collected from a cohort of 20 patients diagnosed with severe COVID-19 and treated with nebulised surfactant (Alveofact®) on a dose escalating manner... Our study has shown the potential utility of SP-D as a marker for lung epithelial damage. The observed direct correlation between SP-D levels and clinical oxygenation parameters underscores the potential of SP-D in reflecting disease severity and progression. These findings not only contribute to our understanding of COVID-19 induced ARDS but also suggest biochemical indices of underlying disease improvement or worsening may help inform clinical management decisions such as pronation, ventilation, and oxygen therapy."

Clinical • Surfactant • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • ACE2

Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Ain Shams University

Immunomodulating • New P1 trial • Acute Respiratory Distress Syndrome • Inflammation • Respiratory Diseases • ELANE • MPO

Drug solubility in biorelevant media in the context of an inhalation-based biopharmaceutics classification system (iBCS). (PubMed, Eur J Pharm Biopharm) - "Their solubility was determined in media representative for the oral (Fasted State Simulated Intestinal Fluid (FaSSIF)) and pulmonary (Alveofact medium and Simulated Lung Fluid (SLF)) routes of administration to confirm the need for a novel approach for inhaled drugs...For other drugs, however, we observed either just small (rifampicin, budesonide, salmeterol) or unexpectedly large differences (beclomethasone dipropionate)...The solubility of drug substances in simulated lung lining fluids was found to be dependent on the physicochemical properties of the drug substance and the composition of the media. While a pulmonary dissolution medium that would fit all drugs could not be established, our approach may provide guidance for finding the most suitable dissolution medium for a given drug substance and better designing in vitro tests for predicting the in vivo performance of inhalable drug products."

Journal

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact (clinicaltrials.gov) - P2 | N=261 | Active, not recruiting | Sponsor: Aerogen Pharma Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Respiratory Distress Syndrome • Respiratory Diseases

Comparing the clinical and economic efficiency of four natural surfactants in treating infants with respiratory distress syndrome. (PubMed, PLoS One) - "So that some criteria were worse in Alveofact group infants than other groups; for example, in the comparison of the Alveofact group with the average of the total population, it was found that the survival rate at discharge was 57.14% versus 66.43%, and the rate of re-dosing was 1.63 versus 1.39. BLES (bovine lipid extract surfactant) was the best alternative for infants more than 32 weeks' gestation, whereas Survanta was identified as best option for infants with less than 32 weeks' gestation...This study advises the policy makers in the field of neonatal health to increase the market share of more effective surfactants based on this study and other similar studies. On the other hand, neonatal health care providers are also advised to prioritize the use of more effective surfactants if possible, depending on the clinical conditions and desired improvements."

Journal • Acute Respiratory Distress Syndrome • Respiratory Diseases