N-Zyme Biomedical Program Receives US$2.76 Million NIH Award to Advance Fosamprenavir for PPI-Refractory GERD
NIH-supported research will evaluate the mechanistic effects of fosamprenavir and support a Phase II randomized,
Press Release Disclaimer: This is a press release distributed through the XPR Media network. It has not been independently verified by our newsroom.
N-Zyme Biomedical Inc. (“N-Zyme”), a clinical-stage biotechnology company developing novel pepsin-targeted therapies for reflux disease, today announced that a research team led by N-Zyme Co-Founder and Chief Scientific Officer Dr. Nikki Johnston has been awarded US$2.76 million through an R01 research grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), to advance the study of fosamprenavir in proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260922925855/en/
N-Zyme Biomedical Program Receives US$2.76 Million NIH Award to Advance Fosamprenavir for PPI-Refractory GERD
The award, administered through the Medical College of Wisconsin (MCW), will support an integrated translational and clinical research program evaluating fosamprenavir, N-Zyme’s lead drug candidate, as a potential treatment for patients with GERD whose symptoms persist despite PPI therapy.
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 evaluate the efficacy of fosamprenavir in patients with PPI-refractory GERD through a Phase II randomized, double-blind, placebo-controlled clinical trial sponsored by N-Zyme Biomedical.
The clinical study will also incorporate single-cell multi-omic analyses of esophageal biopsies collected during the trial, providing an opportunity to characterize biological responses to treatment at high resolution and further investigate the mechanisms underlying PPI-refractory disease.
“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,” said Franco Vigile, Co-Founder and Chief Executive Officer of N-Zyme Biomedical. “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.”
The R01 project is led by Dr. Nikki Johnston, Co-Founder and Chief Scientific Officer of N-Zyme Biomedical and Professor at MCW, together with Co-Principal Investigator Joseph Zenga, MD. The multidisciplinary research team also includes Co-Investigators Jon Gould, MD, MBA; Tina Samuels, PhD; Pelin Ergün, MSc, PhD; Alexandra Vandenberg, CCRC; and Ke Yan.
“This NIA R01 project aims to transform the therapeutic landscape for PPI-refractory GERD by repurposing fosamprenavir and providing robust clinical and molecular insights,” said Nikki Johnston. “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.”
N-Zyme is developing fosamprenavir as a novel therapeutic approach to reflux disease based on inhibition of pepsin, a digestive enzyme increasingly implicated in reflux-related tissue injury. Unlike conventional therapies focused primarily on suppressing gastric acid, N-Zyme’s approach is designed to target pepsin-mediated injury as a distinct component of reflux disease.
N-Zyme will serve as the sponsor of the Phase II clinical trial. The company maintains an exclusive patent license agreement with MCW covering intellectual property underlying its pepsin-inhibition therapeutic program, positioning N-Zyme to advance and commercialize resulting therapeutic applications in accordance with the terms of its license.
The newly funded PPI-refractory GERD program complements N-Zyme’s ongoing clinical development efforts in laryngopharyngeal reflux (LPR), where the company is currently advancing fosamprenavir through Phase II clinical evaluation.
“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
Research described in this press release is supported by the National Institute on Aging (NIA) of the National Institutes of Health (NIH) under Award Number 1R01AG097515-01. The award is administered through the Medical College of Wisconsin.
The content of this announcement is the responsibility of N-Zyme Biomedical and does not necessarily represent the official views of the National Institutes of Health.
About N-Zyme Biomedical
N-Zyme Biomedical Inc. is a clinical-stage biotechnology company developing first-in-class pepsin-targeted therapeutics for reflux disease. The company’s lead program is evaluating the repurposed HIV protease inhibitor fosamprenavir as an inhibitor of pepsin for the treatment of laryngopharyngeal reflux and PPI-refractory gastroesophageal reflux disease. N-Zyme is advancing clinical programs designed to address an important unmet need among patients whose symptoms are not adequately controlled by existing acid-suppressive therapies.
For more information, visit N-Zyme Biomedical’s website or follow N-Zyme on LinkedIn, Instagram, Facebook and X at @nzymebio.
Forward-Looking Statements
This press release contains forward-looking statements regarding N-Zyme Biomedical’s clinical development programs, the potential therapeutic effects of fosamprenavir, planned and ongoing clinical trials, and the potential development and commercialization of product candidates. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied. Fosamprenavir has not been approved by the U.S. Food and Drug Administration or other regulatory authorities for the treatment of GERD or LPR.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260922925855/en/
Media gallery
