N-Zyme Biomedical has secured a $2.76 million NIH award to advance its Phase II trial of fosamprenavir for PPI-refractory gastroesophageal reflux disease (GERD). The trial aims to explore cellular mechanisms and potential biomarkers to enhance personalized treatment strategies.
The randomized Phase II trial will ... 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 ... 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. NIH-supported research will evaluate the mechanistic effects of fosamprenavir and support a Phase II randomized, double-blind, placebo-controlled clinical trial in patients with PPI-refractory GERD · WAUWATOSA, Wis. & NEWARK, Del.--(BUSINESS WIRE)--#Award--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. 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. 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). 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.
Original title: “N-Zyme Biomedical Program Receives US$2.76 Million NIH Award to Advance Fosamprenavir for PPI-Refractory GERD - BioSpace”