N-Zyme Biomedical Inc., a Wauwatosa, WI- and Newark, DE-based clinical-stage biotech developing pepsin-targeted therapies for reflux disease, announced on September 22, 2026 that a research team led by Co-Founder and Chief Scientific Officer Dr. Nikki Johnston has been awarded $2.76 million through an R01 research grant from the National Institute on Aging (NIA), part of the NIH, to advance the study of fosamprenavir in proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD). The award, administered through the Medical College of Wisconsin (MCW), will fund an integrated translational and clinical research program evaluating N-Zyme’s lead drug candidate in patients whose GERD symptoms persist despite PPI therapy.
Franco Vigile, Co-Founder and CEO of N-Zyme Biomedical, said: “This US$2.76 million NIH award represents an important validation of the scientific work underlying our fosamprenavir program and significantly expands the resources available to investigate its potential in PPI-refractory GERD. Importantly, this is non-dilutive funding that will support both mechanistic research and a Phase II clinical trial without requiring additional equity capital from N-Zyme. We are extremely proud of Nikki and the entire research team for achieving this milestone and grateful to the NIA and NIH for supporting this important work.”
Two Goals: Understanding the Mechanism, Then Testing It in Patients
The NIH-funded project has two primary objectives. First, investigators will evaluate fosamprenavir’s prodrug conversion, mucosal-protective properties, and anti-inflammatory effects across multiple esophageal model systems of PPI-refractory GERD. Second, the project will test fosamprenavir’s efficacy in a Phase II randomized, double-blind, placebo-controlled clinical trial sponsored by N-Zyme. The clinical study will also incorporate single-cell multi-omic analyses of esophageal biopsies collected during the trial, allowing researchers to characterize biological responses to treatment at high resolution and further probe the mechanisms behind PPI-refractory disease. The R01 project is led by Johnston — also a Professor at MCW — together with Co-Principal Investigator Joseph Zenga, MD, and a multidisciplinary team of co-investigators: Jon Gould, MD, MBA; Tina Samuels, PhD; Pelin Ergün, MSc, PhD; Alexandra Vandenberg, CCRC; and Ke Yan.
Johnston said: “This NIA R01 project aims to transform the therapeutic landscape for PPI-refractory GERD by repurposing fosamprenavir and providing robust clinical and molecular insights. Through an innovative combination of pharmacologic, molecular and clinical approaches, this study aims to identify new strategies to preserve mucosal integrity, reduce inflammation and improve symptom burden, particularly in aging populations where GERD management remains challenging. The randomized Phase II trial will provide important data on the efficacy of fosamprenavir, while the on-trial multi-omic analyses will investigate cellular mechanisms that could guide personalized and precision-based approaches. The research may also identify potential biomarkers and combinatorial strategies for future interventions, with the potential to advance the treatment paradigm for GERD and inform future clinical development.”
Targeting an Enzyme
N-Zyme’s approach centers on inhibiting pepsin, a digestive enzyme increasingly implicated in reflux-related tissue injury, rather than the conventional strategy of suppressing gastric acid alone. N-Zyme will serve as sponsor of the Phase II trial and holds an exclusive patent license agreement with MCW covering the intellectual property underlying its pepsin-inhibition program. This newly funded GERD program adds to N-Zyme’s existing work in laryngopharyngeal reflux (LPR), where the company is already advancing fosamprenavir through its own Phase II clinical trial. “This award allows us to expand the clinical development of fosamprenavir across two major areas of reflux disease while preserving shareholder capital,” Vigile added. “Together with our ongoing Phase II LPR program, we believe this represents another important step in building a comprehensive clinical and scientific foundation for pepsin inhibition as a new therapeutic strategy in reflux disease.”
Funding Acknowledgment
The research is supported by the National Institute on Aging under award number 1R01AG097515-01, administered through the Medical College of Wisconsin. The content of the announcement reflects N-Zyme Biomedical’s own views and doesn’t necessarily represent the official views of the NIH.
About N-Zyme Biomedical
N-Zyme Biomedical is a clinical-stage biotechnology company developing first-in-class pepsin-targeted therapeutics for reflux disease. Its lead program evaluates the repurposed HIV protease inhibitor fosamprenavir as a pepsin inhibitor for both laryngopharyngeal reflux and PPI-refractory GERD, targeting patients whose symptoms aren’t adequately controlled by existing acid-suppressive therapies. Fosamprenavir has not been approved by the FDA or other regulatory authorities for either indication.
