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Recombinant Human Surfactant Protein-D

A groundbreaking Phase 3 clinical trial is underway to investigate the effectiveness of Zelpultide Alfa, a recombinant human surfactant protein-D, in preventing bronchopulmonary dysplasia (BPD) in high-risk premature infants. This study aims to compare the efficacy of Zelpultide Alfa added to standard care versus standard care plus placebo in reducing the incidence of severe BPD and death in these vulnerable newborns.

Table of Contents

What is Zelpultide Alfa?

Zelpultide alfa, also known as AT-100 or Recombinant Human Surfactant Protein-D (rhSP-D), is a new medication being studied to help prevent lung problems in very premature babies[1]. It’s a type of protein that’s similar to a natural substance found in the lungs.

How Does It Work?

Zelpultide alfa is designed to protect the lungs of premature babies. It’s a type of medicine called a surfactant, which helps keep the tiny air sacs in the lungs open and working properly[1]. This is especially important for premature babies because their lungs are not fully developed yet.

Who Is This Treatment For?

This treatment is being studied for very premature babies who are at high risk of developing a serious lung condition called bronchopulmonary dysplasia (BPD)[1]. BPD is a chronic lung disease that can occur in premature infants, especially those born between 23 and 28 weeks of pregnancy.

Current Clinical Trial

Zelpultide alfa is currently being tested in a Phase 3 clinical trial[1]. This is an important step in determining if the medication is safe and effective. The study is comparing zelpultide alfa added to standard care versus standard care alone in premature babies.

The main goals of the study are to see if zelpultide alfa can:

  • Reduce the number of babies who develop severe BPD or die[1]
  • Decrease other breathing problems related to being born prematurely[1]
  • Improve long-term brain development[1]
  • Reduce the need for medical care and associated costs[1]

Potential Benefits

If successful, zelpultide alfa could help:

  • Prevent or reduce the severity of BPD in premature babies[1]
  • Reduce the time babies need to spend on breathing machines[1]
  • Improve overall health outcomes for premature infants[1]

How Is It Given?

Zelpultide alfa is given directly into the baby’s lungs through a breathing tube. It’s given along with standard care for premature babies[1]. The maximum daily dose being tested is 6 mg per kilogram of the baby’s weight, and the treatment may be given for up to 7 days[1].

It’s important to note that this medication is still being studied and is not yet approved for general use. The ongoing clinical trial will help determine if it’s safe and effective for premature babies.

Aspect Details
Drug Name Zelpultide Alfa (AT-100)
Active Substance Recombinant Human Surfactant Protein-D (rhSP-D)
Trial Phase Phase 3
Target Population High-risk preterm neonates (23 0/7 to 27 6/7 weeks gestational age)
Primary Objective Compare efficacy in preventing grade 2 and 3 BPD and death
Administration Method Endotracheopulmonary instillation
Maximum Daily Dose 6 mg/kg
Maximum Total Dose 42 mg/kg over 7 days
Primary Endpoint Incidence of grade 2 or 3 BPD or death at week 36 PMA

FAQ

  • What is Zelpultide Alfa? Zelpultide Alfa is a recombinant human surfactant protein-D (rhSP-D) being studied to protect the lungs and prevent lung injury in very premature babies at risk of lung disease.
  • Who is eligible for this clinical trial? The trial includes premature babies born between 23 and 27 weeks of gestation, who have received at least one dose of animal-derived pulmonary surfactant and are on invasive mechanical ventilation.
  • How is Zelpultide Alfa administered? Zelpultide Alfa is given through endotracheopulmonary instillation, which means it's delivered directly into the baby's lungs through the breathing tube.
  • What is the main goal of this clinical trial? The main objective is to compare the effectiveness of Zelpultide Alfa added to standard care versus standard care plus placebo in reducing the occurrence of grade 2 and 3 bronchopulmonary dysplasia (BPD) and death in high-risk premature infants.
  • What are some of the exclusion criteria for this trial? Babies with major congenital abnormalities affecting heart and lung function, those weighing less than 400g or more than 1,500g at birth, and those with a history of allergy to surfactants or components of Zelpultide Alfa are excluded from the trial.

Ongoing Clinical Trials on Recombinant Human Surfactant Protein-D

  • Study to Test if Zelpultide Alfa Helps Prevent Lung Disease in High-Risk Premature Babies

    Recruiting

    4 1
    Investigated drugs:
    Belgium Czechia France Germany Italy Poland +2

Glossary

  • Bronchopulmonary dysplasia (BPD): A chronic lung disease that affects premature infants, characterized by inflammation and scarring in the lungs.
  • Recombinant Human Surfactant Protein-D (rhSP-D): A laboratory-made version of a natural protein found in the lungs that helps reduce inflammation and protect against infections.
  • Endotracheopulmonary instillation: A method of delivering medication directly into the lungs through a breathing tube.
  • Gestational age: The length of pregnancy from the first day of the last menstrual period to birth.
  • Standard of care (SOC): The typical treatment or care given to patients with a specific condition, based on current medical knowledge and practices.
  • Placebo: A substance with no active medical effects, used as a control in testing new drugs.
  • Invasive mechanical ventilation: A method of assisting breathing using a machine that delivers air directly into the lungs through a tube inserted into the windpipe.
  • Postmenstrual age (PMA): The time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).

References

  1. http://clinicaltrials.eu/trial/study-to-test-if-zelpultide-alfa-helps-prevent-lung-disease-in-high-risk-premature-babies/