• Larazotide has received Fast Track designation from the FDA for celiac disease.
• Innovate is preparing to enter Ph III registration clinical trials for celiac disease later in 2018
• Larazotide has demonstrated a favorable safety profile comparable to placebo for long-term chronic administration (over 800 patients)

Innovate Biopharmaceuticals Inc. (Nasdaq:INNT) announced on 7/31/18 it has agreed to collaborate with James P. Nataro, MD, PhD, MBA, the Benjamin Armistead Shepherd Professor and Chair, Director of Children's Services, UVA Children's Hospital of the University of Virginia School of Medicine, whose research is focused on the study of enteric bacteria and their roles in health and disease.

Dr. Nataro commented, “I am excited by this collaboration.  Abnormalities of intestinal permeability underlie a host of human diseases such as environmental enteric dysfunction, known as EED.  EED is a disorder that afflicts millions of children around the world, leading to growth faltering, cognitive delay and impaired resistance to infection.”

Dr. Nataro has published extensively on intestinal infection and gut health among children in the U.S. and around the world. Dr. Nataro’s lab is funded by the National Institutes of Health (NIH) and independent foundations.  His current work on larazotide is funded by the Bill and Melinda Gates Foundation.

Larazotide's mechanism of action renormalizes the dysfunctional intestinal barrier by decreasing intestinal permeability and reducing antigen trafficking, such as gliadin fragments in celiac disease, and bacterial toxins and immunogenic antigens in non-alcoholic steatohepatitis (NASH). In several diseases, including celiac disease, NASH, Crohn’s disease, ulcerative colitis, irritable bowel syndrome (IBS), type 1 diabetes mellitus (T1DM), chronic kidney disease (CKD), the intestinal barrier is dysfunctional with increased permeability.

In celiac disease, larazotide is the only drug which has successfully met the primary endpoint with statistical significance in a Phase 2b efficacy clinical trial (342 patients). Innovate successfully completed the End of Phase 2 Meeting with the FDA in 2017 and is preparing to begin Phase 3 registration clinical trials for celiac disease later in 2018. In clinical trials testing of more than 800 patients, larazotide demonstrated a favorable safety profile comparable to placebo for long-term chronic administration. Larazotide has received Fast Track designation from the FDA for celiac disease.