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

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).

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Attendees gather at N-Zyme Biomedical's Phase 2 Clinical Trial Launch Celebration at the Medical College of Wisconsin.

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.

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"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," said Franco Vigile, Co-Founder and Chief Executive Officer of N-Zyme Biomedical.