N-Zyme Biomedical, a pharmaceutical company seeking to provide much-needed treatments for patients that suffer from laryngopharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD), and LGM Pharma, a leading provider of tailored Active Pharmaceutical Ingredients (APIs) and contract development and manufacturing organization (CDMO) services for the full drug product lifecycle, are partnering to develop the world's first pepsin inhibitor drug for reflux disease. This collaboration aims to bring to market a first-in-class treatment that is safe and effective for patients with LPR and/or persistent GERD symptoms that current medications fail to resolve.

Approximately 40–50% of GERD patients continue to experience symptoms despite daily use of the standard-of-care — proton pump inhibitors (PPIs), which are designed to suppress stomach acid. Concerningly, long-term studies indicate that PPIs fail to prevent the progression of reflux-related diseases and malignancies. Recent advancements in diagnostic technology have revealed that while PPIs reduce the acidity of refluxate, they do not decrease its frequency. Nonacid constituents like the gastric enzyme pepsin play a significant role in ongoing symptoms and disease progression. Pepsin is present in all refluxate and promotes inflammation and cancerous changes in the aerodigestive tract, yet it remains unaddressed by current acid-suppressing medications. 

Fosamprenavir, an existing protease inhibitor used to treat HIV, has been found to bind to and inactivate pepsin, preventing pepsin-mediated laryngeal inflammation and damage in preclinical studies. Fosamprenavir has a good safety and tolerability profile, and targets a foreign virus, which is otherwise not present, making it an ideal drug to repurpose allowing safe assessment in a clinical trial. This repurposing approach allows for a more expeditious assessment in a clinical trial compared to a new molecule.

"Modern diagnostic technologies have revealed why a significant percentage of people experience little to no relief with currently available treatment options for reflux," said Franco Vigile, the Co-Founder and CEO of N-Zyme Biomedical. "Our mission is to address this critical unmet need in clinical care. By repurposing fosamprenavir and developing the first pepsin inhibitor for LPR and GERD, we aim to improve the quality of life for the approximately eighty million reflux sufferers in the United States and millions more worldwide.”

N-Zyme Biomedical engaged LGM Pharma as the CDMO of choice to develop a new prolonged-release formulation of fosamprenavir — oral fosamprenavir sodium alginate. This new formulation aims to increase mucoadhesion and prolong drug delivery to the esophagus. LGM Pharma sourced and supplied the active pharmaceutical ingredient (API), developed the novel formulation, and is now manufacturing the clinical trial materials. 

"We are proud to be the outsourcing CDMO partner for this innovative drug development," said Hamilton Lenox, Chief Commercial Officer of LGM Pharma. "Our expertise in managing all phases of the drug product development process—from sourcing and supplying APIs to drug product manufacturing—allows us to support pioneering companies like N-Zyme Biomedical. This partnership aligns with our commitment to providing comprehensive, customer-centric solutions that reduce risk, increase efficiency, and accelerate the path to commercialization."

With fosamprenavir sodium alginate, N-Zyme Biomedical originally targeted LPR, a lesser known and more difficult diagnosis. But in the past year, the company expanded the indication and added GERD. A Phase II clinical trial to assess efficacy for both LPR and GERD is planned to begin enrollment in Spring of 2025, funded by venture capital investment.

To learn more about LPR and GERD, and the new reflux disease therapeutic under development, and the upcoming clinical trials, please visit: www.nzymebio.com.

Resources:
https://www.enthealth.org/conditions/gerd-and-lpr/
https://www.nzymebio.com/about-lpr 

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About LGM Pharma

LGM Pharma is a leading contract development and manufacturing organization (CDMO) providing comprehensive Active Pharmaceutical Ingredient (API) sourcing and drug product CDMO solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries. LGM Pharma assists clients in managing all phases of the drug product development process, from API sourcing through to commercialization. LGM Pharma’s extensive global network of qualified API partners enables clients to optimize supply chain management and distribution. Services include API sourcing and procurement, formulation development, analytical method development, method and process validation, ANDA/NDA submission, stability studies, and raw material and finished product testing and packaging. LGM Pharma is committed to quality and has a long-established positive regulatory track record, providing expert regulatory and market intelligence services to its clients. The company is focused on customer service and customized solutions, providing clients with a comprehensive one-stop manufacturing solution that reduces risk, increases efficiency, and accelerates the path to commercialization. For more information, visit www.lgmpharma.com.