Innovate Biopharmaceuticals, Inc. Announces First Patient Dosed in the First Phase 3 Clinical Trial for Patients with Celiac Disease
CeD LA 3001 trial doses first patient in historic Phase 3 celiac disease trial
Larazotide acetate, or INN-202, is Innovate's leading drug candidate for the treatment of celiac disease. The drug is a tight junction regulator designed to help restore “leaky” or open junctions to a normal state. 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.
This Phase 3 study is a national, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial that is expected to enroll approximately 600 patients. The study’s primary objective is to evaluate larazotide acetate as an adjunct therapy for patients with celiac disease who still experience symptoms despite being on a gluten-free diet. Larazotide is an oral therapy taken prior to meals, up to 3 times per day. Larazotide is not systemically absorbed and has a well-established safety profile.
Sandeep Laumas, M.D., CEO of Innovate, stated, “We are extremely pleased to start patient dosing in this pivotal Phase 3 trial for larazotide for celiac disease. This brings us closer in our mission of gaining approval for the first ever drug for celiac disease.”
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
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Source: Innovate Biopharmaceuticals, Inc