AyuVis Research Inc., a clinical-stage biopharmaceutical company, has received Fast Track designation from the U.S. Food and Drug Administration for an investigational new drug called AVR-48 to prevent a rare lung disease in children.

There are currently no FDA-approved therapies available to prevent or treat bronchopulmonary dysplasia (BPD).

Fast Track designation is designed to accelerate clinical development and review of regulatory submissions for medicines that have the potential to treat serious diseases and address unmet medical needs. The goal is to bring important new medicines to patients more quickly.

“We are very excited to see our project progress in clinical trials,” said AyuVis founder and CEO Dr. Suchi Acharya in a statement. “Receiving all three awards – Orphan Drug, Rare Pediatric Disease and Fast Track Designation – consecutively is a great testament to our team’s diligent efforts to advance the development of AVR-48 and bring preventive therapy to the newborns who need it most.”

AyuVis will have access to regular meetings and written communications with the FDA during clinical development, and AVR-48 may be eligible for accelerated approval and/or priority review.

Premature babies diagnosed with moderate to severe borderline personality disorder at 36 weeks (corrected gestational age) or at discharge from the NICU often have permanent lung damage from inflammation or oxygen toxicity, according to the company. After discharge, they are at risk for rehospitalization, delayed brain development and respiratory problems throughout childhood. Borderline personality disorder can lead to death or lifelong complications, including asthma and chronic obstructive pulmonary disease (COPD).

In addition, AyuVis is developing a new generation of immunotherapies that provide a balanced immune response. To effectively treat BPD, mild activation and controlled suppression of the immune system are required.

“For decades, neonatologists have struggled with BPD because of improved survival rates for extremely premature infants,” said David Riley, chief medical officer of AyuVis and a practicing neonatologist. “With AVR-48, we finally have a potential therapy that can treat the root cause of the disease. I am excited to see progress in the clinical and regulatory process and, if approved, will be eager to bring it to the bedside to improve outcomes in the most vulnerable babies.”

Earlier this year, AyuVis received approval from the FDA to test AVR-48 in human trials. These initial tests, scheduled to begin in 2024, will focus on ensuring the drug’s safety in healthy adults. The study is funded in part by the National Institutes of Health.

AyuVis is a member of the Blue Knight Accelerator, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority (BARDA); a member of TechFW, a nonprofit technology business incubator and accelerator in Fort Worth; and a partner of the HSCNext Innovation Labs at the University of North Texas Health Science Center.