Innovate to Start Phase 3 Celiac Trial in 1H 2019, Announce Top-line NASH Data

Preliminary top-line data from the alcoholic steatohepatitis (ASH) collaboration with Massachusetts General Hospital shows positive effect of larazotide on ethanol-induced permeability in vitro

Innovate Biopharmaceuticals Inc. (Nasdaq: INNT), a clinical stage biotechnology company focused on developing novel medicines for autoimmune and inflammatory diseases, is evaluating various funding proposals for commencing the first ever Phase 3 registration trial for celiac disease. Celiac disease affects approximately 1% of the U.S. population, more than 3 million Americans, and is a high unmet need with no FDA approved treatments available.

Christopher Prior, Ph.D., CEO of Innovate, stated, “We believe that during 2018 we have laid the foundation for an exciting 2019 by completing much of the preparatory work to launch our Phase 3 trial for celiac disease and to expand our pipeline in areas of liver disease.” Dr Prior added, “We are continuing our efforts to secure financing for this trial on favorable terms with the goal of benefiting our stockholders and bringing important medicines to patients where there are no currently available therapies.”

As previously presented, larazotide demonstrated decreased deterioration of gut permeability, in the DIAMOND NASH mouse model, where leaky gut developed by 16 weeks. With ongoing work in drug combinations with Novo Nordisk A/S’s OZEMPIC^®(semaglutide) approved for type 2 diabetes and Intercept Pharmaceuticals Inc.’s OCALIVA^® (obeticholic acid) approved for primary biliary cholangitis (PBC), Innovate expects to release data by EASL 2019.

Through its recent collaboration with Massachusetts General Hospital (MGH) on alcoholic steatohepatitis (ASH), Innovate is announcing preliminary top-line data showing positive effects by larazotide on ethanol-induced permeability in vitro. The MGH model shows larazotide markedly protects and rescues cells from increased ethanol-induced permeability, a known pathologic effect in ASH. Innovate plans to present further details, including transepithelial electric resistance (TEER), and timing of these ethanol induced permeability effects, at an upcoming medical meeting in 2019. Alcoholic liver disease (ALD), including acute-on-chronic forms, such as alcoholic hepatitis, has been shown to lead to hospitalizations (1% of hospital admissions in 2010)¹ and high mortality rates (20–30% at 1 month and 40–70% at 6 months).²

Peter Traber, M.D., an experienced drug developer in NASH and GI, said, “The fact that larazotide is capable of restoring permeability following three different insults, namely gluten, high fat diet and alcohol relevant to celiac disease, NASH and ASH, respectively, underscores the potential broad application for this unique mechanism of action.”

https://www.marketscreener.com/INNOVATE-BIOPHARMACEUTICA-41613116/news/Innovate-Biopharmaceuticals-Plans-to-Commence-the-First-Ever-Phase-3-Registration-Trial-in-Celiac-27763158/