AyuVis, incubated in HSC, receives FDA fast-track designation for drug to prevent lung disease in premature babies

Receiving Fast Track designation from the FDA accelerates development of AVR-48, which could prove to be a breakthrough in preventing bronchopulmonary dysplasia in premature infants.

AyuVis Research Inc., a clinical-stage biopharmaceutical company based at the University of North Texas Health Science Center at HSC Next Innovation Labs in Fort Worth, recently announced that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational drug AVR-48.

This designation relates to the potential use of the AVR-48 vaccine in the prevention of bronchopulmonary dysplasia, a leading cause of mortality and long-term complications in premature infants.

“We are incredibly proud of AyuVis’ achievements and the potential impact it will have on the lives of premature babies,” said Dr. Katrina Gordon, associate director of entrepreneurship at HSC Next. “This success story exemplifies the power of our labs to support and nurture healthcare startups that drive life-changing advances.”

AyuVis’ journey began at HSC Next Innovation Labs, a state-of-the-art facility designed to support healthcare startups. With access to world-class research infrastructure, expert mentoring, and essential resources, the labs enable companies like AyuVis to accelerate from concept to impactful innovation.

AVR-48, developed by AyuVis, is a new treatment that has the potential to significantly improve the care of premature babies. These babies are at risk of BPD, which is caused by long-term inflammation and damage from oxygen therapy. AVR-48 aims to significantly improve outcomes by preventing BPD and reducing the risk of related conditions such as asthma and chronic obstructive pulmonary disease.

The FDA’s Fast Track designation provides an expedited review process for AVR-48, which could result in the drug reaching patients sooner. This expedited timeline offers hope to families facing the challenges of preterm birth, offering the potential to improve health outcomes for infants at risk for BPD.

“This recognition is a significant milestone in our journey to develop breakthrough immunotherapies for the prevention of BPD,” said Dr. Suchi Acharya, founder and CEO of AyuVis. “It underscores our commitment to addressing unmet medical needs and brings us closer to offering this critical solution to pediatric patients.”

AyuVis’ progress reflects the value of a collaborative and supportive environment for healthcare innovators. HSC Innovation Labs remains committed to providing the resources and expertise companies like AyuVis need to grow and make a global impact.

“HSC has played a critical role in our growth and success,” Acharya said. “The university’s state-of-the-art research facilities, talented trainees, and collaborative programs have given us the foundation on which to bring our ideas to life. Our partnership has created an ecosystem where innovation can truly flourish.”