Franco Vigile had recently sold the genetic-based pre-screening company he founded and was in Mexico celebrating when he woke up one morning unable to swallow. A doctor there treated it as a bacterial infection, but a course of injectable antibiotics did nothing to alleviate his symptoms. Back in Canada, the swelling came and went depending on what he ate and drank. Five months in and still without an answer, he started digging through the research himself, until he landed on a diagnosis no doctor had reached.
It was laryngopharyngeal reflux, or LPR. Where common reflux produces heartburn, LPR extends higher into the throat and airway, causing hoarseness, chronic cough and the sensation of a lump in the throat.
A target with no drug
Once he understood the mechanism, the treatment failures made sense. The damage in LPR comes from pepsin, not acid. Pepsin is the enzyme the stomach uses to break down protein, and when it travels up into the throat, it goes on breaking down the tissue there. Since commonly used reflux drugs such as antiacids, H2 blockers and proton pump inhibitors only reduce acid they do not alleviate LPR symptoms.
The scale was what struck Vigile. As much as 20% of the US population experiences LPR symptoms to one degree or another, and the role of pepsin was already well established in the literature. Yet no pepsin inhibitor existed. “I couldn’t believe it,” he said. “If this many people have LPR, where is the pepsin inhibitor?”
His research led him to Dr. Nikki Johnston. A professor of otolaryngology and communication sciences and of microbiology and immunology at the Medical College of Wisconsin, where Dr. Johnston runs its Pepsin and Reflux Laboratory. Her research had shown that fosamprenavir—an approved HIV protease inhibitor—binds to and inhibits pepsin, preventing pepsin-mediated inflammation and tissue damage in preclinical studies.
They spoke over the following months and decided to build a company together to make a drug for a condition that has none. N-Zyme Biomedical was incorporated in August 2021, with Dr. Johnston as chief scientific officer and Vigile as chief executive.
A 2022 Falk Medical Research Trust Transformational Award, granted to develop an inhaled formulation, carried a GLP toxicology requirement, and the Medical College of Wisconsin engaged KreaMedica to plan and manage the non-clinical safety work through its functional outsourcing model. The Montreal firm has supported more than 150 development programs, acting as general contractor across its CRO and CMO network. It was, at that stage, a straightforward toxicology engagement.
Where the program stalled
The difficulty came on a different front. Alongside the inhaled treatment, N-Zyme was developing an oral formulation, and the next step brought a change in requirements. Early regulatory work had proceeded under an investigator-sponsored IND, and when the company moved to take that program commercial with a modified formulation, the agency’s expectations shifted with it.
“The FDA looked at that IND and said, this needs to be a commercial IND since you’re changing the formulation,” said Kristi Miller, PhD, founder of Indevric Consulting and a regulatory professional with more than 20 years of industry experience. “When they did that, they weren’t aware of the CMC ramifications in particular.”
That gap happens often in academic spinouts, and it is rarely a science problem. Chemistry, manufacturing and controls requirements are substantially higher for a commercial submission, and the advisors who serve an investigator-sponsored study well are frequently not the ones who know what a commercial IND has to contain.
After discussions with the agency, N-Zyme withdrew the submission rather than press ahead. “That was smart,” Miller said. “By withdrawing the application altogether, you can wipe the slate clean and put your best foot forward.” Pushing ahead would most likely have ended in a clinical hold, which stays on the regulatory record and must be addressed in every filing that follows. Withdrawing protected both the timeline and a working relationship with the agency that the company will rely on for years.
The right experts at the right moment
KreaMedica had by then been working with the team since the toxicology studies. When N-Zyme needed help preparing its IND and producing both the drug and the placebo, Dr. Johnston learned that the firm’s capabilities ran further than toxicology, and president and CEO Karl-Rudolf Erlemann pointed her to KreaConnect, the platform KreaMedica uses to match companies with specialist consultants.
“We don’t have regulatory FDA experience, so that was new for us,” Dr. Johnston said. Rather than improvise, the founders went looking for partners who did.
Through KreaConnect, KreaMedica brought in Miller on regulatory strategy and Danny Dinh, who runs an independent CMC consultancy in California, on chemistry and manufacturing. Both engagements began as gap analyses and grew from there. “The original scope was relatively small,” Miller said. “One of the things that worked well was that we came to them not only raising questions but with solutions.”
The manufacturing side needed the most work. The Phase 2 study is randomized, double-blind and placebo-controlled, which meant N-Zyme had to produce placebo tablets to a standard the FDA would accept before it could run the trial at all. Dinh’s first recommendation was a structural one, which was to keep the advisory and the manufacturing roles in separate hands. “You have to be independent,” he said. “One party does part A, a different party does part B, so you have an independent view of what you’re doing.”
That meant changing manufacturers. Dinh introduced the founders to Latitude Pharmaceuticals in San Diego and has coordinated the CMC work from there. He and Miller also proposed a change in sequence that shortened the path to the clinic, which was to run the first trial with tablets while the preferred sustained-release formulation continued in development.
Those introductions were the moment the program changed direction. “Everyone brings their own unique skills to the table to put together that full team,” Miller said. “It’s making sure you have the right experts in the room.”
The founders describe something beyond the expertise. “It really felt like they were not only consultants but members of our team,” Dr. Johnston said. “Sometimes when you engage professionals through a consulting agreement, the mindset can feel very corporate,” Vigile added. “Danny and Kristi have their heart in it. They’re invested. They really want to see it succeed.”
What comes next
The Phase 2 trial opened in June 2026 and is now enrolling, a randomized, double-blind, placebo-controlled study of oral fosamprenavir in adults with LPR, and the first clinical test of a pepsin-targeted therapy. The study needs 104 participants. Roughly 500 people had volunteered before enrollment opened, and Latitude is now shipping the drug to the site. The plan from here is to generate the human efficacy data and partner with companies equipped to carry the drug through commercialization.
“I know how isolating it can feel when you’re trying everything,” Vigile said. “Patients shouldn’t lose hope. Many of the most meaningful businesses are built from real human problems. We’re trying to build something that will genuinely improve people’s lives.”