N-Zyme Biomedical Launches Phase 2 Trial of First Pepsin Inhibitor for Laryngopharyngeal Reflux, Secures $4.6M Series A
核心洞察
N-Zyme Biomedical (搜索) has initiated a Phase 2 clinical trial evaluating its lead pepsin inhibitor candidate, fosamprenavir, for the treatment of laryngopharyngeal reflux (搜索) (LPR), a condition with no FDA-approved pharmacological therapy.
The company closed a $4.6 million Series A financing round to support the ongoing LPR trial and a planned Phase 2 study in PPI-refractory gastroesophageal reflux disease (搜索) (GERD).
N-Zyme's approach targets pepsin directly rather than suppressing gastric acid, addressing a key mechanism underlying persistent and treatment-resistant symptoms that proton pump inhibitors (搜索) fail to resolve.
N-Zyme Biomedical (搜索), a Delaware-based clinical-stage biotechnology company, announced the initiation of its Phase 2 clinical trial evaluating a first-in-class pepsin inhibitor for the treatment of laryngopharyngeal reflux (搜索) (LPR). The trial, led by Dr. Nikki Johnston at the Medical College of Wisconsin, represents 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.
The milestone comes alongside the company's first disclosed institutional equity raise: a Series A financing round totaling approximately $4.6 million. The funding drew participation from healthcare professionals, entrepreneurs, a venture capital group, and strategic investors, though no lead investor was named.
"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," said Franco Vigile, Co-Founder and Chief Executive Officer of N-Zyme Biomedical (搜索). "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."
A Novel Mechanism Targeting Pepsin
Unlike traditional acid-suppressing therapies, including proton pump inhibitors (搜索) (PPIs), which do not address non-acidic components of reflux, N-Zyme's approach is designed to target pepsin directly. Pepsin remains partially active even at higher pH levels reached during PPI therapy, and research from the company's academic origins has demonstrated that pepsin can be internalized into epithelial cells and reactivated intracellularly, contributing to persistent symptoms despite acid suppression.
N-Zyme's lead approach repurposes fosamprenavir, an FDA-approved HIV protease inhibitor, based on structural similarities between HIV protease and pepsin—both aspartic proteases. This enzyme therapeutics strategy aims to address an underlying mechanism of tissue injury rather than simply reducing acid output.
Phase 2 Trial Design and Pipeline
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 (搜索). LPR, often referred to as "silent reflux," remains significantly underdiagnosed and undertreated, with many patients continuing to experience chronic symptoms despite standard therapies. The condition currently has no FDA-approved pharmacological treatment.
Beyond the ongoing LPR trial, the company plans a second Phase 2 program in PPI-refractory gastroesophageal reflux disease (搜索) (GERD), using a sustained-release oral fosamprenavir-sodium alginate formulation. An earlier-stage aerosolized formulation for LPR is also in development, with GLP inhalation toxicology studies underway. Proceeds from the Series A will fund both Phase 2 programs, along with regulatory, manufacturing, and business development activities.
Intellectual Property and Academic Origins
N-Zyme Biomedical (搜索) originated from research conducted at the Medical College of Wisconsin, where co-founder and Chief Scientific Officer Nikki Johnston led laboratory work characterizing pepsin's pathological role in reflux disease and identifying amprenavir's pepsin-inhibitory activity. Johnston is named as sole inventor on the foundational patent covering HIV protease inhibitors for reflux indications. Vigile, the company's business co-founder, is himself a patient with LPR.
In parallel with its clinical advancement, 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.
Prior to the Series A, N-Zyme relied on non-dilutive funding, including two Falk Medical Research Trust awards, and had already advanced its lead candidate into the clinic, beginning its Phase 2 LPR trial in June 2026. With the financing complete, the company said it is positioned to advance its clinical programs and pursue additional strategic partnerships, having recently participated in the BIO Investment & Growth Summit to explore further collaboration opportunities.