Aerosurf (lucinactant) / Windtree Therap, Dompe, Esteve, Lee's Pharm - LARVOL DELTA

A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age (clinicaltrials.gov) - P2 | N=12 | Terminated | Sponsor: Windtree Therapeutics | Suspended ➔ Terminated; Corporate business reasons

Trial termination • Acute Respiratory Distress Syndrome • Respiratory Diseases

The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age (clinicaltrials.gov) - P2; N=221; Completed; Sponsor: Windtree Therapeutics; Active, not recruiting ➔ Completed

Clinical • Trial completion • Acute Respiratory Distress Syndrome • Respiratory Diseases

A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks GA (clinicaltrials.gov) - P2; N=12; Suspended; Sponsor: Windtree Therapeutics; N=90 ➔ 12; Recruiting ➔ Suspended

Clinical • Enrollment change • Trial suspension • Acute Respiratory Distress Syndrome • Respiratory Diseases

Windtree Announces FDA Acceptance of IND Application for a Phase 2 Clinical Trial Studying KL4 Surfactant in Acute Lung Injury in Adults with COVID-19 (PRNewswire) - "Windtree Therapeutics, Inc....today announced that United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for a Phase 2 clinical trial studying lyo lucinactant....The Company plans to start the study within the next several weeks and expects recruitment to take 3-6 months....If the initial Phase 2 study results demonstrate adequate safety/tolerability and efficacy...Windtree would plan to initiate two additional clinical trials. One study would more fully assess the impact of KL4 surfactant....The second study would be to utilize the Company's novel and proprietary Aerosolized Delivery System (ADS) to aerosolize and deliver the KL4 surfactant noninvasively in COVID-19 patients..."

IND • New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks GA (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Windtree Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Respiratory Distress Syndrome • Respiratory Diseases

A Randomized, Controlled Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks GA (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Windtree Therapeutics

Clinical • New P2 trial

Deposition of Aerosolized Lucinactant in Nonhuman Primates. (PubMed, J Aerosol Med Pulm Drug Deliv) - "Lucinactant for inhalation is an investigational noninvasive, aerosolized surfactant replacement therapy for treatment of preterm neonates with respiratory distress syndrome. Aerosolized lucinactant, delivered using the ADS via constant flow nCPAP, is deposited in all regions of the lungs demonstrating that surfactant can be aerosolized and delivered noninvasively to NHPs."

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