Press Releases 6th June,2017

Innovate Biopharmaceuticals to present progress towards phase 3 celiac disease trials at BIO 2017 Convention

RALEIGH, N.C., June 6 — Innovate Biopharmaceuticals, a leader in developing innovative therapies for autoimmune and inflammatory diseases, will present on its phase 3 drug for celiac disease at BIO 2017 in San Diego on June 19th at 2:45pm PT in Theater 4.

Innovate’s lead drug candidate, larazotide acetate (INN-202), has successfully completed the End of Phase 2 Meeting to prepare for phase 3 clinical trials for larazotide in celiac disease later this year. Larazotide is the only drug which has successfully met its primary endpoint in an efficacy clinical trial for celiac disease. Larazotide has received Fast Track designation from the FDA. In clinical studies in more than 800 patients, larazotide has demonstrated a highly favorable safety profile comparable to placebo, due to its lack of systemic absorption from the gut.

Larazotide is a novel oral peptide with a unique mechanism of action (MOA) which decreases intestinal permeability and regulates tight junctions by reducing antigen trafficking across epithelial cells in the intestines. Larazotide is the only drug, to our knowledge, in the clinic with this unique MOA. Increased intestinal permeability has been recognized as a gateway to multiple autoimmune diseases including celiac disease, irritable bowel syndrome (IBS), inflammatory bowel disease (Crohn’s and ulcerative colitis), type 1 diabetes mellitus (T1DM), nonalcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and several others.

About Celiac Disease

Celiac disease, an autoimmune disorder that is triggered by the ingestion of gluten, affects 3 million people in the United States and approximately 15 million individuals worldwide. People with celiac disease who are exposed to gluten experience an immune reaction in their small intestines, causing damage to the inner surface (villi) of the small intestine, and an inability to absorb certain nutrients. Signs and symptoms of celiac disease include intestinal pain, bloating, diarrhea and failure to thrive (infants and small children). These symptoms can be reduced, and sometimes eliminated, by avoiding food that contains gluten. However, many patients remain symptomatic despite a gluten-free diet, and these patients may benefit from the addition of pharmacotherapy. Currently, there are no pharmacological therapies available to treat celiac disease.


Innovate’s second therapeutic, INN-108, is expected to enter phase 2 trials in early 2018. INN-108, a small molecule prodrug that only becomes activated in the colon, is being developed for the treatment of an adult orphan indication and for mild-to- moderate ulcerative colitis. An oral liquid formulation is also in development for pediatric and elderly patients.

Recent Accolades for Innovate Biopharma

• Awarded the Best Late-Stage Company Award from Triangle Business Journal, a publication covering the Research Triangle region of Raleigh-Durham-Chapel Hill

• Named a finalist in the Buzz of BIO Pipelines of Promise competition ahead of the BIO 2017 International Convention

Forward Looking Statements

This press release contains forward-looking statements, including statements regarding the clinical development of our product candidates, which are subject to risks and uncertainties that could cause actual results to differ materially. Reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates; and risks of increased regulatory requirements, amongst others. These forward-looking statements speak only as of the date hereof. Innovate Biopharmaceuticals disclaims any obligation to update these forward-looking statements.

SOURCE:Innovate Biopharmaceuticals:

Investor Relations

Kendyle Woodard

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