Funding Will Support U.S. Clinical Development in Extremely Preterm Infants
Airway Therapeutics, Inc. has received a $1.9 million grant from the National Institutes of Health (NIH) to support its U.S. clinical trial of zelpultide alfa.
The funding will be used for the company's Phase 2b clinical trial evaluating zelpultide alfa for the prevention of bronchopulmonary dysplasia (BPD) in extremely preterm infants.
The grant, identified as R44HL186892, was awarded through the NIH's National Heart, Lung, and Blood Institute (NHLBI) and its Small Business Innovation Research (SBIR) program.
The $1.9 million represents non-dilutive funding, meaning Airway Therapeutics does not have to give up company ownership in exchange for the grant.
The funding will support the company's late-stage clinical development program for BPD, a serious lung condition for which there are currently no approved preventive treatments.
What Is Bronchopulmonary Dysplasia?
Bronchopulmonary dysplasia is a chronic lung disease that mainly affects babies born very prematurely.
Extremely preterm infants are born before their lungs have fully developed. Their immature lungs can be damaged by inflammation, infection and other stresses associated with intensive respiratory care after birth.
BPD can lead to long-term breathing problems and can require extended medical care.
The condition develops during a period when the infant's natural lung defense systems are still developing.
Why Extremely Preterm Infants Are at Risk
The lungs of extremely premature babies do not have the same protective mechanisms as fully developed lungs.
One important protein involved in lung protection is surfactant protein D, commonly called SP-D.
SP-D is part of the body's natural immune defense system in the lungs.
It helps regulate inflammation, recognize and clear pathogens, and maintain the balance of substances needed for normal lung function.
In premature infants, these protective functions may not yet be fully developed.
This can leave the developing lungs more vulnerable to inflammation, infection and injury.
How Zelpultide Alfa Is Designed to Work
Zelpultide alfa is being developed as a recombinant human surfactant protein D treatment.
In simple terms, it is designed to replace or restore some of the protective functions that may be missing or insufficient in the immature lungs of extremely premature infants.
Airway Therapeutics says zelpultide alfa has been engineered to closely reproduce the structure and biological activity of naturally occurring human SP-D.
The treatment uses advanced cell-line technology to optimize its glycosylation, a process involving the attachment of sugar molecules to proteins that can affect their structure and biological function.
Three Main Functions of Zelpultide Alfa
Zelpultide alfa is designed to support lung health through several biological mechanisms.
First, it is intended to regulate immune responses and reduce excessive inflammation in the developing lungs.
Second, it is designed to improve the recognition and clearance of pathogens. This could help strengthen the lungs' natural defense against infections.
Third, zelpultide alfa is intended to support surfactant homeostasis.
Surfactant is a substance that helps keep the small air sacs in the lungs open and supports normal breathing. Maintaining the right balance of surfactant-related functions is important for developing lungs.
Together, these mechanisms are intended to provide protection during the vulnerable period after birth.
Phase 2b Trial Is Underway
Airway Therapeutics is evaluating zelpultide alfa in a Phase 2b clinical program in the United States.
The study is designed to evaluate the safety and effectiveness of zelpultide alfa in high-risk extremely preterm infants.
Researchers are comparing the treatment with standard treatment to determine whether zelpultide alfa can reduce the incidence and severity of BPD.
The study will also provide additional information about the safety and tolerability of the treatment.
The U.S. program builds on earlier clinical work with zelpultide alfa, including a Phase 1b study that showed a favorable safety and tolerability profile.
International Clinical Development Is Also Underway
The zelpultide alfa development program is not limited to the United States.
The company has also reported the successful start of its clinical trial program in Europe, Argentina and Israel.
The international program provides additional clinical experience as Airway Therapeutics evaluates the potential of zelpultide alfa in premature infants at high risk of developing BPD.
The company is using data from these studies to support the continued development of the treatment.
NIH Funding Supports Late-Stage Development
The new NIH grant provides Airway Therapeutics with additional funding as the company moves forward with clinical development.
Because the grant comes through the SBIR program, it is designed to support small businesses developing technologies and treatments with potential medical applications.
Airway Therapeutics said the funding will strengthen its ability to execute its late-stage development strategy for BPD.
Marc Salzberg, MD, chairman and CEO of Airway Therapeutics, said the NIH grant recognizes the scientific relevance of the company's program and the need for new preventive approaches to BPD.
He said the company remains focused on evaluating whether zelpultide alfa can improve clinical outcomes in extremely preterm infants at risk of developing the disease.
Zelpultide Alfa Is Being Developed as a Broader Biologic Platform
Although prevention of BPD in premature infants is currently the main indication, Airway Therapeutics is also exploring zelpultide alfa for other respiratory, inflammatory and infectious diseases.
The company describes zelpultide alfa as a biologic platform that could potentially be used across different age groups.
Its development is focused on using the biological functions of SP-D to influence inflammation, immune defense and lung function.
The company is exploring potential applications in adults as well as infants.
These additional applications remain under development and will require separate clinical studies to determine their safety and effectiveness.
Phase 2b/3 Development for BPD
The prevention of BPD is currently being evaluated in a Phase 2b/3 clinical development program.
The program follows the Phase 1b study, which provided initial safety and tolerability data.
The later-stage studies are intended to provide more information about whether zelpultide alfa can reduce the number of extremely preterm infants who develop BPD and whether it can reduce the severity of the disease among those who do.
The results of these studies will help determine the next steps in the development program.
Airway Therapeutics’ Focus on Respiratory Diseases
Airway Therapeutics is a biopharmaceutical company focused on developing biologic treatments for respiratory, inflammatory and infectious diseases.
The company's lead candidate is zelpultide alfa.
Its main clinical focus is currently the prevention of BPD in extremely premature infants.
The company is also investigating whether the same biologic approach can be applied to other respiratory and inflammatory conditions.
What Comes Next for Zelpultide Alfa?
The $1.9 million NIH grant will support the ongoing U.S. clinical development of zelpultide alfa.
Airway Therapeutics will continue evaluating the treatment in high-risk extremely preterm infants while gathering additional safety and efficacy data from its international clinical program.
The key question for the ongoing studies is whether restoring SP-D-related protective functions can reduce inflammation, infection-related injury and other factors that contribute to BPD.
Further clinical results will determine how the zelpultide alfa program progresses toward potential future regulatory submissions and broader development.
