AyuVis
Suchismita Acharya
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, AVR-48, designed to prevent a rare pediatric lung disease.
There currently are no FDA-approved therapies available for the prevention or treatment of bronchopulmonary dysplasia, or BPD.
Fast Track Designation is designed to expedite the clinical development and the review of the marketing applications for drugs that have the potential to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
“We are very excited about the progress of our project into clinical trials,” said AyuVis founder and CEO Dr. Suchi Acharya in a statement. Getting all three designations — Orphan Drug, Rare Pediatric Disease, and Fast Track Designation — one after another is a great testament to our team's diligent effort to expedite the development of AVR-48 and bring preventive therapy to the neonates most in need.”
AyuVis will have access to frequent meetings and written communications with the FDA during clinical development, and AVR-48 may be eligible for accelerated approval and/or priority review.
Preterm babies that are diagnosed with moderate to severe BPD at 36 weeks corrected gestational age or at discharge from the NICU often have permanent damage to their lungs by inflammation or oxygen toxicity, according to the company. After discharge, there is a risk of rehospitalization, delayed brain development, and respiratory problems throughout childhood. BPD could lead to death or life-long complications, including asthma and chronic obstructive pulmonary disease, or COPD.
Additionally, AyuVis is developing a new generation of immunotherapies that provide a well-balanced immune response. Mild activation and controlled immune system suppression is needed to treat BPD effectively.
“For decades, neonatologists have struggled with BPD as a consequence of the improved survival of extremely premature infants,” said David Riley, AyuVis chief medical officer and a practicing neonatologist. “We finally have a potential therapy in AVR-48 to treat the root cause of the disease. I am excited to see its progress through 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 start testing AVR-48 in human trials. These initial tests, set to begin in 2024, will focus on ensuring the drug's safety in healthy adults. The study will be partially funded 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 in The University of North Texas Health Science Center HSCNext Innovation Labs.