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Premature birth is a major health concern that can result in death or significant disability. While it has long been known that dysfunctional lungs are of major importance, it wasn’t until Dr. Mary Ellen Avery set out to understand the disease that we came to understand the fundamental problem. In 1959, Dr. Avery demonstrated that underdeveloped lungs in preterm babies are unable to produce a key liquid biomaterial now known as “lung surfactant”. Four years later, Patrick Kennedy, the third child of Jackie and President John F. Kennedy, was born more than 5 weeks early. Patrick died 2 days after his birth due to respiratory distress syndrome (RDS), known at the time as hyaline membrane disease. His tragic death put a major spotlight on this problem and with Dr. Avery’s discovery, scientists began seeking ways to enable breathing in these infants.

 One critical area of research sought to find a biomaterial that would substitute for lung surfactant. However, clinical trials conducted in 1964 and 1967 failed and scientists were discouraged from pursuing work in this area for the next 10 years. It wasn’t until the early 1980s that Drs. Tore Curstedt and Bengt Robertson demonstrated that animal lungs extracts contain a mixture of lung-specific proteins and phospholipids that support breathing of preterm babies with RDS. Today there are treatments available made from the lungs of pigs, cows, and calves.

So why make a synthetic lung surfactant? For many reasons, including:

  • Animal-derived products pose an ever-present danger of contamination with dangerous pathogens.
  • Raising dedicated herds to harvest lung tissue is environmentally unfriendly and does not scale to meet the increasing scope of the disease.
  • The current products require cold storage. This increases cost, limits distribution and therefore accessibility.
  • Although we know that mixing lung surfactant with other lung treatments greatly enhances therapeutic activity, it is not feasible to do this with animal-derived products.

These and other limitations have underscored a 20-year effort to establish bioengineered lung surfactants. This effort is crucial not only to help preterm babies survive and thrive, but also for adults suffering from serious respiratory disease, such as Acute Lung Injury. The biggest roadblock has been the inability to make surfactant-specific proteins that are fully active. This is where BioSuperior stands alone. We are making key components that closely match the structure and activity of the human versions. And we have incorporated this material into our prototype product, BioSurf. We plan to test our drug candidate in human clinical trials starting in 2024. I look forward to our innovation helping shape the future of lung surfactant so more lives can be saved.

For more information, I refer readers to Dr. Michael Stephen’s book “Breath Taking”, and a review by Dr. Henry Halliday in J Paediatrics (vol. 53, 2017).

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