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Company advancing a first-in-class approach to targeting pepsin, with the potential to redefine the standard of care; recently granted patents from the U.S. Patent and Trademark Office and Japan Patent Office, strengthening its intellectual property position WAUWATOSA, Wis. & NEWARK, Del.--(BUSINESS WIRE)-- #Biotech -- 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). 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,” 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.” 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. Contacts Franco Vigile CEO and Co-Founder Franco.vigile@nzymebio.com

Dive Brief:Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash its pulled in from venture capitalists this year to further its drug discovery.Its latest round was led by Premji Invest, the family office of Indian billionaire Azim Premji, and included backing from a mix of tech and biotechnology investors such as Kinnevik, Dimension and Lux Capital.Enveda also announced it has started Phase 1b testing of its lead drug candidate in atopic dermatitis. Several other experimental drugs are expected to enter human trials in the coming year.Dive Insight:Founded in 2019, Enveda launched with the goal of building an artificial intelligence platform to discover new drugs. It says its technology can mine large datasets to find promising molecules that already exist in nature.Nature has been running the most sophisticated R&D program on Earth for billions of years, yet nearly all of its chemistry remains unexplored, said Viswa Colluru, Envedas CEO, in a statement.Its lead program, dubbed ENV-294, is a small molecule Enveda claims is a completely new chemical class that showed kinase inhibitor-like and steroid-like behavior in preclinical testing, and a safety profile similar to biologics in toxicology studies. Early study data released in May showed ENV-294 was well tolerated in trial participants, with no serious adverse events reported.Enveda is aiming at “very large markets, large indications that affect broader society, and plans to tackle diseases that are driven by more than one mechanism, said Daniel Wee, Enveda's chief execution officer.Last year, the company raised $130 million in Series C funding led by Kinnevik and FPV. Sanofi joined Enveda's investor group in February, helping to boost its total haul to $150 million.By banking capital, the company aims to get several of its programs into the clinic. “In startups, at the growth stage, you never let up off the gas, Wee said.Enveda plans to file investigational new drug applications for other programs over the next year. In its pipeline are an NLRP3/TL1A+ pathway inhibitor for inflammatory bowel disease, another TL1A+ inhibitor for various inflammatory and fibrotic conditions and a hormone mimetic for obesity. Twelve other programs are disclosed.The theory of leveraging what life has already created and building on top of that will give us a better success rate, Wee said.Supporters of AI-designed drugs have touted the technology as a way to reduce the amount of time and money spent on finding new molecules. But few have entered clinical testing, and even fewer have yielded data. Those that have showed mixed results.Former Pfizer Chief Scientific Officer Mikael Dolsten will also join Envedas board of directors. '