Innovate Biopharmaceuticals Announces Start of First Phase 3 Clinical Trial


Innovate Biopharmaceuticals, Inc. recently announced the start of the first Phase 3 clinical trial in celiac disease. Innovate expects to provide further updates as screening and enrollment proceed over the next few months.

Innovate’s Chief Medical Officer, Dr. Patrick H. Griffin, stated “We are proud to start the first ever Phase 3 clinical trial to address a large unmet need for celiac patient suffering from continued symptoms in spite of being on a gluten-free diet.”

Innovate’s Chairman and CEO, Dr. Sandeep Laumas, added “This is a landmark event in the history of celiac disease for the first ever Phase 3 trial to get underway as well as a key pivotal moment for Innovate. We are especially thankful to our partners, physicians and our investors whose support of Innovate’s management has led to this outcome.”

Innovate is a clinical stage biotechnology company focused on developing novel therapeutics for autoimmune and inflammatory diseases. Innovate’s lead drug candidate, larazotide acetate, has a mechanism of action that 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 nonalcoholic 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.

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