InfasurfAero (calfactant aerosolized) / Ony Biotech - LARVOL DELTA

Aero-05: InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: ONY | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Respiratory Diseases

Aero-05: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: ONY | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

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

High vs Low CPAP Strategy with Aerosolized Calfactant in Preterm Infants with Respiratory Distress Syndrome (PAS 2024) - "A total of 321 infants were included in the study (215 in the low CPAP group and 106 in the high CPAP group). Those in the high CPAP group tended to be of greater GA, be older at time of first aerosolization, have fewer aerosol treatments overall, and have lower FiO2 levels (Table 1). Clinical outcomes of CPAP failure, pneumothorax and death were not different between the two groups (Table 2)."

Prematurity • Acute Respiratory Distress Syndrome • Critical care • Respiratory Diseases

Aero-05: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: ONY | Trial completion date: Sep 2025 ➔ Dec 2025 | Initiation date: Apr 2024 ➔ Jul 2024

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

High vs low CPAP strategy with aerosolized calfactant in preterm infants with respiratory distress syndrome. (PubMed, J Perinatol) - "We found no difference in CPAP failure among infants who received aerosolized calfactant that were treated with high vs low CPAP strategy. Efficacy of high CPAP strategy with aerosolized surfactant treatment needs to be evaluated in future studies."

Journal • Acute Respiratory Distress Syndrome • Respiratory Diseases

Aero-05: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: ONY | Initiation date: Oct 2023 ➔ Apr 2024

Trial initiation date • Acute Respiratory Distress Syndrome • Respiratory Diseases

Aero-05: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: ONY

New P3 trial • Acute Respiratory Distress Syndrome • Respiratory Diseases

Predictors of successful treatment of respiratory distress with aerosolized calfactant. (PubMed, J Perinatol) - "Gestational age, number of aerosols, and RSS are predictive of successful treatment. These criteria will help select patients most likely to benefit from aerosolized surfactant."

Journal

Response to aerosolized calfactant in infants with respiratory distress syndrome; a post-hoc analysis of AERO-02 trial. (PubMed, J Perinatol) - "FiO, MAP, and RSS were lower in the UC group. This is likely due to early and higher rate of liquid surfactant administration in the UC group. Decrease in FiO was noted in the AC group after the first aerosolization."

Journal • Retrospective data • Acute Respiratory Distress Syndrome • Respiratory Diseases

A Single-Center Experience with Aerosolized Calfactant in the Treatment of Respiratory Distress Syndrome (PAS 2023) - P3 | "Between 2017 and 2022, we administered aerosolized calfactant to 177 neonates. Twenty-four neonates (13.6%) required rescue intubation, surfactant via endotracheal tube, and mechanical ventilation. In infants < 29 weeks gestation, 2/4 (50%); between 29 to 33 6/7 weeks gestation, 37/45 (82.2 %); and infants ≥ 34 weeks, 114/128 (89.1%) never required rescue intubation."

Clinical • Acute Respiratory Distress Syndrome • Respiratory Diseases

Response to Aerosolized Calfactant in Preterm Infants with Respiratory Distress Syndrome; A Post Hoc Analysis of AERO-02 trial (PAS 2023) - "Final study cohort consisted of 189 subjects in AS group and 164 in UC group. Forty-eight percent of subjects in the UC group required intubation at median age of 5 hours compared to 24% subjects in the AS group at a median age of 22 hours (Figure 1). FiO2, MAP and RSS were lower in the UC group for the 72 hours from randomization (Figure 2)."

Prematurity • Retrospective data • Acute Respiratory Distress Syndrome • Respiratory Diseases