CLINICAL TRIALS PROFILE FOR LUCINACTANT

All Clinical Trials for Lucinactant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004500 ↗	Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome	Terminated	Windtree Therapeutics	Phase 3	2000-03-01	OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
NCT00215540 ↗	SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.	Terminated	Windtree Therapeutics	Phase 2	2005-02-01	SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).
NCT00215553 ↗	KL₄Surfactant Treatment in Patients With ARDS	Terminated	Windtree Therapeutics	Phase 2	2001-05-01	Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
NCT00578734 ↗	Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old	Completed	Windtree Therapeutics	Phase 2	2007-06-01	Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).
NCT00807235 ↗	Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants	Terminated	Windtree Therapeutics	Phase 2	2005-01-01	To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
NCT00934362 ↗	Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease	Completed	Cystic Fibrosis Foundation	Phase 2	2008-10-01	Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.
NCT00934362 ↗	Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease	Completed	Cystic Fibrosis Foundation Therapeutics	Phase 2	2008-10-01	Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.

Clinical Trial Conditions for Lucinactant

Condition Name

Condition Name for Lucinactant
Intervention	Trials
Respiratory Distress Syndrome	3
Respiratory Distress Syndrome, Newborn	1
Acute Hypoxemic Respiratory Failure	1
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)	1

Condition MeSH

Condition MeSH for Lucinactant
Intervention	Trials
Respiratory Distress Syndrome, Newborn	6
Respiratory Distress Syndrome, Adult	6
Respiratory Distress Syndrome	5
Syndrome	3

Clinical Trial Locations for Lucinactant

Trials by Country

Trials by Country for Lucinactant
Location	Trials
United States	35
Poland	14
Canada	5
Chile	4
Colombia	2

Trials by US State

Trials by US State for Lucinactant
Location	Trials
California	4
Pennsylvania	4
North Carolina	4
Rhode Island	2
Oregon	2

Clinical Trial Progress for Lucinactant

Clinical Trial Phase

Clinical Trial Phase for Lucinactant
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Lucinactant
Clinical Trial Phase	Trials
Terminated	4
Completed	3
Recruiting	2

Clinical Trial Sponsors for Lucinactant

Sponsor Name

Sponsor Name for Lucinactant
Sponsor	Trials
Windtree Therapeutics	9
Cystic Fibrosis Foundation	1
Cystic Fibrosis Foundation Therapeutics	1

Sponsor Type

Sponsor Type for Lucinactant
Sponsor	Trials
Industry	9
Other	3
NIH	1

Lucinactant: Clinical Trials, Market Analysis, and Projections

Introduction to Lucinactant

Lucinactant, also known as SURFAXIN, is a synthetic lung surfactant designed to treat respiratory distress syndrome (RDS) and other respiratory conditions. It is part of the KL4 surfactant platform, which has been the focus of several clinical trials and market analyses.

Clinical Trials Update

Phase I/II and Phase III Trials for RDS in Infants

Lucinactant has undergone extensive clinical trials, particularly for the prevention of RDS in premature infants. The Phase I/II trials conducted between 2000 and 2003 involved 22 patients and focused on safety, adverse events, and pulmonary inflammatory markers[3].

The pivotal Phase III trial, known as SELECT (Safety and Effectiveness of Lucinactant vs. Exosurf in a Clinical Trial), enrolled 1,294 premature infants across Latin America and Europe. This trial demonstrated statistically significant improvements in RDS outcomes for infants treated with lucinactant compared to those treated with colfosceril palmitate (Exosurf)[3].

Another Phase III trial, STAR (surfaxin therapy against RDS), compared lucinactant with Curosurf, a leading animal-derived surfactant, and showed favorable outcomes for lucinactant[3].

Phase 2 Trial for COVID-19 Associated ARDS

Recently, Windtree Therapeutics completed a Phase 2 study evaluating the safety and tolerability of lucinactant in patients with COVID-19 associated acute respiratory distress syndrome (ARDS) and lung injury. This multicenter, single-arm study enrolled 20 critically ill patients who were intubated and on mechanical ventilation. The results indicated that intratracheal administration of reconstituted lyophilized lucinactant was generally safe and well-tolerated, with stable or improved oxygenation and other physiological outcomes[1][4][5].

Key findings from this study include:

• The administration procedure was easier and faster with fewer peri-dosing side effects compared to earlier trials using a different formulation of lucinactant.
• The treatment approach showed feasibility for developing a potential treatment for critically ill patients with severe ARDS due to COVID-19 or other causes[4].

Market Analysis

Market Size and Growth

The global lung surfactants market, which includes lucinactant, is projected to grow at a CAGR of 4.30% from 2022 to 2029, reaching a market size of USD 242.28 million by 2029 from USD 173.00 million in 2021[2].

The pulmonary surfactant market, more broadly, was valued at USD 578.7 million in 2022 and is expected to reach USD 822.9 million by 2030, driven by increasing research and development activities, particularly during the COVID-19 pandemic[5].

Market Segmentation

The lung surfactants market is segmented by indication (Respiratory Distress Syndrome (RDS), Respiratory Infections, Others), drugs (Poractant, Beractant, Lucinactant, Calfactant, Others), route of administration (Intratracheal, Injectable), end-users (Hospitals, Specialty Clinics, Homecare, Others), and distribution channels (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Others)[2].

Key Drivers and Restraints

Key drivers of the market include:

• Increasing healthcare expenditure and improvements in healthcare infrastructure.
• Government initiatives to spread awareness about lung surfactants.
• Growing research and development activities, especially in the context of COVID-19[2].

However, the market also faces restraints such as:

• High costs associated with drug development and distribution.
• Lack of healthcare infrastructure in developing economies.
• Dearth of skilled professionals and strict government regulations[2].

Market Projections

Future Growth Opportunities

The market is expected to benefit from several growth opportunities, including:

• Increased investment in advanced technologies.
• Expansion into emerging markets.
• Rising awareness and favorable government initiatives[2].

Regional Insights

The lung surfactants market is analyzed by country, indication, drug, route of administration, end-users, and distribution channels. Regional insights suggest varying growth rates and market dynamics across different regions, with significant potential in both developed and emerging markets[2].

Key Takeaways

• Lucinactant has shown promising results in clinical trials for treating RDS in infants and ARDS in COVID-19 patients.
• The global lung surfactants market is expected to grow significantly over the next few years, driven by increasing research and development and favorable market conditions.
• Key drivers include healthcare expenditure, government initiatives, and technological advancements, while restraints include high development costs and infrastructure challenges.

FAQs

What is lucinactant used for?

Lucinactant is used to treat respiratory distress syndrome (RDS) in premature infants and is being investigated for treating acute respiratory distress syndrome (ARDS) in critically ill patients, including those with COVID-19.

What were the key findings of the Phase 2 trial for COVID-19 associated ARDS?

The Phase 2 trial found that intratracheal administration of reconstituted lyophilized lucinactant was safe and well-tolerated, with stable or improved oxygenation and other physiological outcomes in critically ill patients with COVID-19 associated ARDS.

How is the global lung surfactants market projected to grow?

The global lung surfactants market is projected to grow at a CAGR of 4.30% from 2022 to 2029, reaching a market size of USD 242.28 million by 2029.

What are the main drivers of the lung surfactants market?

Key drivers include increasing healthcare expenditure, government initiatives to improve healthcare infrastructure, and growing research and development activities.

What are the major restraints facing the lung surfactants market?

Major restraints include high costs associated with drug development and distribution, lack of healthcare infrastructure in developing economies, and strict government regulations.

Sources

1. Windtree Completes Enrollment in Its Phase 2 Study of Lucinactant (KL4 Surfactant) for COVID-19 Associated Lung Injury and Acute Respiratory Distress Syndrome. Windtree Therapeutics. Retrieved February 1, 2022.
2. Global Lung Surfactants Market Size, Share & Industry Analysis Report Till 2029. Data Bridge Market Research.
3. Surfaxin (Lucinactant) - Treatment for Preventing Infant RDS. Clinical Trials Arena. Retrieved April 25, 2012.
4. Windtree Announces Results from Its Phase 2 Study of Lucinactant for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and Lung Injury. Windtree Therapeutics. Retrieved March 22, 2022.
5. Pulmonary Surfactant Market Size, Trends and Forecast to 2030. Coherent Market Insights.