RALEIGH – Innovate Biopharmaceuticals is launching a phase 3 clinical trial for a treatment targeting celiac disease, which is hereditary and affects millions.

It’s the first time a potential drug has reached phase 3 development, according to the Raleigh-based firm.

Innovate Biopharmaceuticals

Innovate Biopharmaceuticals

“Innovate expects to provide further updates as screening and enrollment proceed over the next few months,” the company said.

“Celiac disease is a serious autoimmune disease that occurs in genetically predisposed people where the ingestion of gluten leads to damage in the small intestine. It is estimated to affect 1 in 100 people worldwide. Two and one-half million Americans are undiagnosed and are at risk for long-term health complications,” says the Celiac Disease Foundation.

“When people with celiac disease eat gluten (a protein found in wheat, rye and barley), their body mounts an immune response that attacks the small intestine. These attacks lead to damage on the villi, small fingerlike projections that line the small intestine, that promote nutrient absorption. When the villi get damaged, nutrients cannot be absorbed properly into the body.”

In a statement, Dr. Patrick Griffin, chief medical officer at Innovate, noted:

“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.”

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Added Innovate’s Chairman and CEO, Dr. Sandeep Laumas: “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 (Nasdaq: INNT) is targeting a variety of autoimmune and inflammatory diseases.

The company also has successfully raised several millions of dollars in funding from a variety of sources to help fund the clinical trial.

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