NEWARK, DE — N-Zyme Biomedical has begun a Phase 2 clinical trial of its lead drug candidate for laryngopharyngeal reflux, advancing a treatment approach that targets pepsin rather than stomach acid in a market where many patients continue to experience symptoms despite existing therapies.
The clinical-stage biotechnology company is evaluating a pepsin inhibitor based on fosamprenavir, a previously approved compound with an established safety profile. The study will assess the therapy’s safety and effectiveness in patients diagnosed with laryngopharyngeal reflux, commonly known as LPR or “silent reflux.”
The trial marks a development milestone for N-Zyme’s effort to commercialize what it describes as a new class of reflux therapeutics. Current standard treatments, including proton pump inhibitors, focus primarily on suppressing stomach acid but do not directly address non-acidic components of reflux.
Laryngopharyngeal reflux affects the throat and voice box and is frequently associated with chronic symptoms that can persist despite conventional treatment. N-Zyme’s strategy centers on inhibiting pepsin, an enzyme the company identifies as a significant contributor to tissue damage and symptom development in reflux disease.
“For decades, the standard of care has focused primarily on acid suppression, despite growing evidence supporting the role of pepsin in disease pathology,” Co-Founder and Chief Executive Officer Franco Vigile said. “We believe targeting pepsin represents a differentiated approach with the potential to redefine how reflux disease is treated.”
The study is being led by Dr. Nikki Johnston at the Medical College of Wisconsin and is expected to generate data on the therapeutic potential of pepsin inhibition in patients with LPR.
Alongside the clinical program, N-Zyme disclosed that it recently received patent protection in both the United States and Japan covering the use of fosamprenavir for the treatment of reflux disease.
The patents strengthen the company’s intellectual property position as it advances development of therapies targeting pepsin and seeks to establish a foothold in the reflux treatment market.
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