Fosamprenavir calcium

N-Zyme Biomedical, a clinical-stage company headquartered in Delaware, announced the initiation of a Phase II trial of fosamprenavir for laryngopharyngeal reflux (LPR), marking the first clinical test of a pepsin inhibitor in reflux disease and a direct challenge to the decades-long dominance of acid suppression as the therapeutic paradigm for this condition. The significance lies in the molecule’s mechanism: while proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs) reduce gastric acid, they do not address pepsin, the proteolytic enzyme that research increasingly implicates as a primary driver of tissue damage in LPR and other extraesophageal reflux manifestations. Fosamprenavir, the molecule N-Zyme is repurposing, is a well-characterized antiretroviral prodrug with an established human safety profile from its prior use in HIV therapy – marketed by ViiV Healthcare/GSK as Lexiva/Telzir. After identifying its function as a pepsin inhibitor, N-Zyme has recently secured patents from both the US Patent and Trademark Office and the Japan Patent Office covering its use in reflux indications. The trial is led by Dr. Nikki Johnston at the Medical College of Wisconsin, who has published extensively on pepsin’s role in LPR pathology. Competitive context The reflux treatment landscape is currently being reshaped by the P-CAB class. Phathom Pharmaceuticals’ Voquezna (vonoprazan) is approved in the US for erosive GERD, non-erosive GERD, and H. pylori eradication, while Sebela Pharmaceuticals’ tegoprazan has an NDA under FDA review with a decision anticipated in January 2027 following positive Phase III TRIUMpH data. Both agents, however, share the same fundamental limitation as PPIs: they suppress acid without targeting pepsin, leaving a subset of patients — particularly those with LPR — without adequate symptom control. Cross-trial comparisons are limited by differences in patient populations and endpoint definitions, but N-Zyme’s pepsin-directed approach is mechanistically distinct from all current approved therapies and any known late-stage pipeline program. LPR, often called “silent reflux,” is characterized by symptoms including chronic cough, hoarseness, and throat clearing, and is notoriously difficult to treat with standard acid-suppressive regimens. The patient population that fails PPIs and P-CABs represents a commercially and clinically meaningful unmet need, though the precise size of the addressable LPR market remains difficult to quantify given chronic underdiagnosis. The Phase II trial is expected to generate efficacy and safety data that will determine whether the pepsin inhibition hypothesis translates into clinical benefit — a question that the field has lacked the tools to answer until now. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Company advancing a first-in-class approach to targeting pepsin, with the potential to redefine the standard of care; recently granted patents from the U.S. Patent and Trademark Office and Japan Patent Office, strengthening its intellectual property position WAUWATOSA, Wis. & NEWARK, Del.--(BUSINESS WIRE)-- #Biotech -- N-Zyme Biomedical , a clinical-stage biotechnology company developing a novel class of therapeutics targeting pepsin in reflux disease, today announced the initiation of its Phase 2 clinical trial to evaluate its lead pepsin inhibitor candidate for the treatment of laryngopharyngeal reflux (LPR). The trial represents a key milestone in the development of what is believed to be the first therapeutic approach specifically designed to inhibit pepsin, a primary driver of tissue damage and symptoms in reflux disease. Unlike traditional acid-suppressing therapies, including proton pump inhibitors (PPIs)that do not address non-acidic components of reflux, N-Zyme’s approach is designed to target pepsin directly—addressing a key mechanism underlying persistent and treatment-resistant symptoms. LPR, often referred to as “silent reflux,” remains significantly underdiagnosed and undertreated, with many patients continuing to experience chronic symptoms despite standard therapies. By targeting pepsin, N-Zyme is advancing a differentiated approach with the potential to improve outcomes across a large and underserved patient population. “The initiation of our Phase 2 trial marks an important milestone for N-Zyme and the advancement of a new therapeutic approach in reflux disease,” said Franco Vigile , Co-Founder and Chief Executive Officer of N-Zyme Biomedical. “For decades, the standard of care has focused primarily on acid suppression, despite growing evidence supporting the role of pepsin in disease pathology—particularly in LPR and other extraesophageal manifestations of reflux. We believe targeting pepsin represents a differentiated approach with the potential to redefine how reflux disease is treated and improve outcomes for millions of patients.” Strengthened Intellectual Property Portfolio In parallel with the advancement of its clinical program, N-Zyme recently expanded its intellectual property portfolio with the issuance of patents covering the use of fosamprenavir for the treatment of reflux disease from both the United States Patent and Trademark Office and the Japan Patent Office. These patents provide strategic protection for the use of fosamprenavir and related compounds in reflux indications and further support the company’s position in developing therapies targeting pepsin. About the Phase 2 Trial The Phase 2 clinical trial is designed to evaluate the efficacy and safety of N-Zyme’s pepsin inhibitor candidate, utilizing fosamprenavir, a well-characterized molecule with an established safety profile, in patients diagnosed with laryngopharyngeal reflux. The trial is led by Dr. Nikki Johnston at the Medical College of Wisconsin and is expected to generate data supporting the therapeutic potential of pepsin inhibition. About N-Zyme Biomedical N-Zyme Biomedical is a clinical-stage biotechnology company headquartered in Delaware, United States. The company is developing a novel class of therapeutics designed to inhibit pepsin, with the goal of advancing the treatment of reflux disease and addressing a significant unmet medical need. Contacts Franco Vigile CEO and Co-Founder Franco.vigile@nzymebio.com