Innovate Biopharmaceuticals Announces First Patient Dosed in the First Phase 3 Clinical Trial

Innovate Biopharmaceuticals, Inc. recently  announced it has dosed the first patient in its Phase 3 clinical trial, CeD LA 3001. This marks the first time any company has dosed a patient in a Phase 3 trial for celiac disease.

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 US 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.

Patrick Griffin, MD, FACP, Innovate’s Chief Medical Officer, said “We are thrilled to announce the first patient dosed in our Phase 3 trial. We believe larazotide will have a meaningful impact on celiac patients and provide a therapy where none is approved. Progressing this trial is another step towards bringing a potentially groundbreaking therapy for celiac patients globally.”

Sandeep Laumas, MD, CEO of Innovate, added “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 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). Larazotide has been exposed to nearly 600 subjects in clinical trials demonstrating a favorable safety profile comparable to placebo for long-term chronic administration. Larazotide has received Fast Track designation from the FDA for celiac disease.