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N-Zyme Biomedical Begins Phase 2 Trial of First Pepsin Inhibitor for Reflux Disease

Business

N-Zyme Biomedical Begins Phase 2 Trial of First Pepsin Inhibitor for Reflux Disease
Business

Business

N-Zyme Biomedical Begins Phase 2 Trial of First Pepsin Inhibitor for Reflux Disease

2026-06-10 19:04 Last Updated At:19:30

WAUWATOSA, Wis. & NEWARK, Del.--(BUSINESS WIRE)--Jun 10, 2026--

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).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610221836/en/

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,” saidFranco 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.

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

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

BUNIA, Congo (AP) — Confirmed cases in Congo's ongoing Ebola outbreak have reached 3,262, its Ministry of Health said in an overnight update, nearly the same as the 2018-2020 outbreak that is the largest ever recorded in the country.

Data from the Congolese health ministry showed that 1,437 patients have died out of the 3,262 cases, in what officials have said is the fastest Ebola outbreak on record, concentrated in the eastern Ituri province.

The 2018-2020 outbreak that was recorded in Congo and neighboring Uganda lasted roughly two years, with more than 3,400 reported cases, including over 2,200 deaths, according to the U.S. Centers for Disease Control.

Only the 2014-2016 outbreak across West Africa, considered the worst in history, had a higher toll with 28,000 cases and more than 11,000 deaths.

The speed of transmission in the current outbreak comes amid concerns from residents that many communities in the affected provinces are either unreachable or have been abandoned by responders in recent days over safety concerns amid attacks from angry residents and rebels.

“The fact that, in just 10 weeks, we have reached nearly the same number of cases recorded over an almost two-year outbreak is alarming and should stop us in our tracks," Onesphore Bangenza, Mercy Corps response team lead in Bunia, Ituri's capital, said Tuesday.

“There is no doubt that the virus is moving faster than we can contain it,” Bangenza added.

The ongoing outbreak, which was declared on May 15, is unlike most previous Ebola outbreaks because the Bundibugyo virus responsible for it has no approved vaccines or treatments.

Efforts to slow the transmission have been challenged by rebel violence in eastern Congo as well as health workers striking to protest the nonpayment of their wages.

The outbreak continues to spread faster than health officials can track despite an expanding response. A key challenge is that patient zero has yet to be identified in the outbreak while displacement from armed conflict and illegal mining in the region have made it difficult to trace thousands who have come in contact with infected individuals.

Despite distrust between communities and health workers mostly seen at the early stages of the outbreak, signs of progress have emerged.

“We can never again wage war against the Ebola teams. We have lost members of our families. As a community, we have a vested interest in fighting Ebola to return to normal life,” said Fabrice Mumbesa, a resident of Mongbwalu, a mining town at the center of the outbreak where residents previously burned down several treatment centers.

——

McMakin reported from Dakar, Senegal

A health worker, wearing protective gear, stands outside the Ebola Treatment Center at the Bunia General Hospital in Ituri, Congo, Wednesday, July 22, 2026. (AP Photo/Dirole Lotsima Dieudonne)

A health worker, wearing protective gear, stands outside the Ebola Treatment Center at the Bunia General Hospital in Ituri, Congo, Wednesday, July 22, 2026. (AP Photo/Dirole Lotsima Dieudonne)

Rubble is set on fire as health and frontline workers protest at the Elikya Ebola Treatment Center in Bunia, Congo, on Saturday, July 25, 2026. (AP Photo/Constant Same Bagalwa)

Rubble is set on fire as health and frontline workers protest at the Elikya Ebola Treatment Center in Bunia, Congo, on Saturday, July 25, 2026. (AP Photo/Constant Same Bagalwa)

Rubble set on fire as health and frontline workers protest at the Elikya Ebola Treatment Center in Bunia, Congo, on Saturday, July 25, 2026. (AP Photo/Constant Same Bagalwa)

Rubble set on fire as health and frontline workers protest at the Elikya Ebola Treatment Center in Bunia, Congo, on Saturday, July 25, 2026. (AP Photo/Constant Same Bagalwa)

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