• Larazotide is a tight junction regulator
• The drug is also in Ph III trials for celiac disease
• The FDA awarded fast track status to Larazotide for celiac
• If approved, Larazotide would be the first drug approved for celiac

Innovate Biopharmaceuticals, Inc. (Nasdaq: INNT), a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases, announced today a potential expanded use for its lead agent, larazotide acetate, with topline preclinical data demonstrating proof-of-concept in an established model of nonalcoholic steatohepatitis (NASH).  Innovate intends to launch a clinical program in NASH with a phase 2 trial in 2019.  There are currently no treatments for nonalcoholic fatty liver disease (NAFLD) or NASH approved by the FDA.

In the study, researchers assessed the effects of larazotide in a preclinical model of NASH that develops from consumption of a specified diet, the DIAMONDTM mouse model.  The preclinical model recapitulates NAFLD/NASH in response to a high fat, high sugar Western diet, including insulin resistance, obesity, and dyslipidemia, which parallels human disease progression, including histopathology.  Researchers aimed to assess the effects of multiple doses of larazotide on various markers of NASH.  In addition, researchers sought to gauge the effects of larazotide on gut integrity, using a highly specific technique measuring epithelial barrier normalization and intestinal permeability.  This measure demonstrated with statistically high significance that larazotide at the doses tested had a clear benefit in reducing gut barrier permeability, a known pathological abnormality in chronic liver diseases, specifically NASH.  Agents which may prevent this “leaky” barrier to worsen through the progression of NASH are thought to provide a potential advantage in treating this disease.  Innovate plans to submit the complete NASH preclinical results for publication at a major upcoming conference/in 2019.

The company believes that studies investigating the potential for synergy between larazotide and drugs in development for NASH, which are already approved for other indications, should help facilitate a pathway for [finding a drug combination that is effective for treating NASH].  Innovate is studying Novo Nordisk A/S’s Victoza (liraglutide) approved for type 2 Diabetes and Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) approved for primary biliary cholangitis (PBC) in combination with larazotide in preclinical models with the goal of determining the optimal synergistic drug combination with different mechanisms of action.

“We are excited about looking at how larazotide could synergistically work with drugs in late-stage clinical trials for NASH, which are already approved in other indications.  We believe that larazotide’s more upstream mechanism of blocking the inflammatory cascade without impacting the liver directly may support its potential therapeutic effect in NAFLD/NASH,” said Dr. Christopher Prior, Chief Executive Officer of Innovate Biopharmaceuticals, Inc.

In addition to its NASH development program, Innovate began enrolling pateints in a Ph III trial of larazotide in celiac patients earlier in 2018. The study's expected completion date is December of 2020. If approved, larazotide would be the first drug ever approved for celiac disease. There are more than 3 million celiac patients in the US and over 15 million worldwide. Larazotide has fast track status with the FDA for celiac disease.

Larazotide is a synthetic eight amino acid peptide that functions as a tight junction regulator and reverses leaky junctions to their normally closed state.