Wauwatosa, Wis. and Newark, Del. — N-Zyme Biomedical said it has begun a Phase 2 clinical trial evaluating its lead pepsin inhibitor candidate for the treatment of laryngopharyngeal reflux.
The clinical-stage biotechnology company is developing a new class of therapies targeting pepsin in reflux disease. The trial marks a key milestone for what the company said 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, which do not address non-acidic components of reflux, N-Zyme’s approach is designed to target pepsin directly.
Laryngopharyngeal reflux, often called “silent reflux,” remains underdiagnosed and undertreated, with many patients continuing to experience chronic symptoms despite standard therapies. N-Zyme said targeting pepsin could offer a differentiated approach for a large 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.”
The Phase 2 trial will evaluate the efficacy and safety of N-Zyme’s pepsin inhibitor candidate, using fosamprenavir, in patients diagnosed with laryngopharyngeal reflux. The study is being led by Dr. Nikki Johnston at the Medical College of Wisconsin.
N-Zyme said fosamprenavir is a well-characterized molecule with an established safety profile. The trial is expected to generate data supporting the therapeutic potential of pepsin inhibition.
The company also said it recently strengthened its intellectual property portfolio with patents from the U.S. Patent and Trademark Office and the Japan Patent Office covering the use of fosamprenavir for the treatment of reflux disease.
The patents provide protection for the use of fosamprenavir and related compounds in reflux indications and support N-Zyme’s strategy of developing therapies targeting pepsin.
