DOYLESTOWN, PA — Advent Therapeutics, Inc. has been awarded a $3 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase IIB grant. This grant allows the Company to position its novel aerosolized vitamin A formulation for commercialization in 2025 to prevent Bronchopulmonary Dysplasia (BPD). BPD is a rare disease and the most common serious complication facing premature infants, resulting in significant morbidity and mortality. There are currently no approved therapies. With this grant, the Company has now received in excess of $6 million from NIH for its neonatal programs.
“This NIH award will allow us to greatly accelerate the development and advance towards approval of our optimized vitamin A drug product,” commented David L. Lopez, Chief Executive Officer, Advent Therapeutics. “Advent’s novel, precisely optimized products are intended to address the unmet medical need of BPD facing premature infants and reduce morbidity and mortality in this fragile patient population. Our primary focus is to accelerate the path to commercialization, first in the US, then EU and worldwide. US launch of Advent’s initial vitamin A drug product for injection is possible in early 2025 with potential peak annual revenues in excess of $100 million for the prevention of BPD. In addition, we intend to pursue broader applications for our novel retinol palmitate drug product that have significant market potential.”
This SBIR Phase IIB grant, awarded under the auspices of both the National Heart, Lung, and Blood Institute (NHLBI) and National Center for Advancing Translational Sciences (NCATS), will support development of Advent’s proprietary aerosolized formulation of vitamin A. The $3 million provided under the SBIR Phase IIB grant will be used to complete preclinical requirements and manufacturing scale-up leading to pivotal human clinical trials with Advent’s inhalable retinol palmitate product to potentially gain US and other worldwide marketing approvals.
Dr. Virender Rehan, Advent’s Principal Investigator at the Lundquist Institute, Professor of Pediatrics, David Geffen School of Medicine at UCLA, Chief of the Division of Neonatology, and Director of the Neonatal Intensive Care Unit, Harbor-UCLA Medical Center, said, “BPD is the most frequent serious complication that affects roughly 15,000 infants annually in the US, with an even greater number of premature infants at risk. With no approved drugs for BPD, these fragile, at-risk premature infants require prolonged mechanical ventilation or oxygen support and lengthy hospital stays often resulting in recurring hospitalizations and pulmonary infections. A baby with BPD adds significant emotional constraints for the family and financial burden to the healthcare system.”
Advent has longstanding collaborations with Dr. Rehan and the world-renowned Lundquist Institute for Biomedical Innovation. The Lundquist Institute is one of the foremost independent, non-profit research institutes in the US and is partnered with Harbor-UCLA Medical Center.
Dr. Virender continued, “I am extremely pleased to be involved in developing Advent’s novel form of inhalable vitamin A therapy. This product has the potential to be a “first-in-class” therapy capable of non-invasively delivering a safe and effective aerosolized vitamin A dose directly to the neonate’s lung. A lung-targeted inhalation therapy that could effectively reduce development of BPD would have significant clinical, financial, and societal implications by directly addressing co-morbidities suffered by these fragile patients.”
Advent has previously been awarded Orphan Drug Designation in both US and Europe for its proprietary vitamin A formulation. Orphan Drug Designation provides incentives including assistance with drug development process and exemption from user fees, as well as a seven-year window of exclusive US marketing rights (10 years in Europe) following marketing approval.
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