NEWARK, DE — N-Zyme Biomedical Inc. secured $2.76 million in federal research funding to advance fosamprenavir into a Phase II trial for patients whose gastroesophageal reflux disease persists despite proton pump inhibitor treatment, expanding the biotech’s clinical program without requiring additional equity capital.
The R01 grant from the National Institute on Aging, part of the National Institutes of Health, will fund research into the drug’s biological effects and support a randomized, double-blind, placebo-controlled clinical trial in patients with PPI-refractory GERD.
The award is administered through the Medical College of Wisconsin, where N-Zyme co-founder and Chief Scientific Officer Nikki Johnston is a professor. Johnston leads the project with co-principal investigator Joseph Zenga.
N-Zyme will sponsor the Phase II trial. The study will evaluate fosamprenavir’s efficacy while researchers separately examine its prodrug conversion, mucosal-protective properties and anti-inflammatory effects across multiple esophageal models.
Researchers will also conduct single-cell multi-omic analyses of esophageal biopsies collected during the trial to examine biological responses to treatment and investigate mechanisms associated with 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,” Chief Executive Officer Franco Vigile said.
The grant provides non-dilutive financing for the research and clinical trial, allowing Newark-based N-Zyme to broaden development of fosamprenavir without raising additional equity for the project.
N-Zyme is developing fosamprenavir as a treatment that inhibits pepsin, a digestive enzyme implicated in reflux-related tissue injury. The approach differs from conventional therapies that primarily suppress gastric acid.
The company maintains an exclusive patent license agreement with the Medical College of Wisconsin covering intellectual property underlying its pepsin-inhibition program.
The new GERD study expands N-Zyme’s clinical work beyond laryngopharyngeal reflux, or LPR, where fosamprenavir is already undergoing Phase II evaluation.
The research team also includes Jon Gould, Tina Samuels, Pelin Ergün, Alexandra Vandenberg and Ke Yan.
Johnston said the Phase II trial is intended to produce efficacy data while the molecular analyses examine cellular mechanisms that could identify biomarkers and inform future clinical development.
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