N-Zyme takes aim at reflux

By Anna Lardinois, Startup Storyteller

An estimated 20% of Americans suffer from laryngopharyngeal reflux (LPR), and as our diets and activity levels change, those numbers continue to increase. The condition causes gastric juices to travel from the stomach, through the esophagus and into the throat. Symptoms of LPR include a chronic cough, difficulty swallowing and hoarseness.

Unlike gastroesophageal reflux disease, commonly known as heartburn, there are no medications available to treat this condition.

N-Zyme is working on changing that.

Dr. Nikki Johnston and Franco Vigile are co-founders of N-Zyme Biomedical Inc. Launched in 2021, the company is in Phase III of the clinical trials required by the U.S. Food and Drug Administration for their proposed treatment of LPR.

While a PhD student in her native Scotland, Johnston began studying gastric reflux. The opportunity to work with internationally recognized LPR expert, Dr. Jamie Koufman, brought her to the United States. Initially, she intended to return to her homeland at the close of her work with Koufman. Instead, she remained in the United States to pursue what would become her life’s passion: developing an effective treatment for LPR.

Johnston was motivated to study LPR because of what she describes as a “significant gap in medical therapy for these patients.”

“From the clinical perspective, the drugs that are available are not effective (for LPR),” she said. “There is really no medical therapy for these patients available, other than certain lifestyle and dietary changes, or surgery. Of course, not everyone can, or wants to, have surgery.”

Traditionally, treatments for LPR focused on stomach acid suppression medication. Through years of studies, she has come to understand that pepsin, not acid, is the underlying cause of LPR. Pepsin is a stomach enzyme that digests the protein in food. Pepsin, stomach acid and bile are the key components of gastric juices.

“As you can imagine, when the enzyme gets up into your throat, knowing what its typical role is, it would cause inflammation and damage,” she said.

When Johnston decided to work on a treatment for LPR, she took what she described as a “two-pronged approach.”

“We were looking at developing a new molecule which would bind to and inhibit pepsin, but alongside that, we screened compounds that are known protease inhibitors,” she said.

Proteases are digestive enzymes released by the stomach that mix with gastric juices to convert proteins into amino acids.

She discovered Fosamprenavir, an existing drug used to treat HIV, was useful in treating LPR. The company is not only pursuing a novel use for the drug, but also working on a reformulation of the drug to make it more useful to LPR patients. N-Zyme is creating both a prolonged release oral formulation of Fosamprenavir and a dry powder inhaler to apply a low dose of Fosamprenavir directly to the throat of LPR patients.

Johnston, an Associate Professor at the Medical College of Wisconsin, has been working on the development of this drug for the past 10 years. She estimates it will be another three or four years before the treatment becomes commercially available.

The long cycle time required for pharmaceutical development has not deterred investors from backing N-Zyme.

“We’ve raised money for the Phase III clinical trial through a seed round of financing primarily reserved for family, friends, and strategic investors. We are raising just what we need at this point in time in the interest of limiting dilution,” Johnston said.

Added Vigile: “We are well capitalized at this point in time and will potentially be looking to raise additional funds in the future as needed. N-Zyme is also applying for a number of grants which will act as non-dilutive financing and help cover testing costs.”

Those suffering from LPR are excited about the promising new treatment.

“We only need 104 people for the Phase III clinicals, and we already have 232 people signed up,” Johnston said. “We’ve got so many people reaching out to us, just desperate. When you think of LPR, you think of the chronic cough and throat clearing, but prolonged, untreated LPR can promote laryngeal cancer.”

To follow the development of this breakthrough treatment for laryngopharyngeal reflux, connect with N-Zyme here.

Franco Vigile, co-founder of N-Zyme

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