Innovate Biopharmaceuticals Plans to Commence the First Ever Phase 3 Registration Trial in Celiac Disease

Innovate Biopharmaceuticals (Nasdaq:INNT), a clinical stage biotechnology company focused on developing novel medicines for autoimmune and inflammatory diseases, is evaluating various funding proposals for commencing the first ever Phase 3 registration trial for celiac disease.

As quoted in the press release:

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 available.

Christopher Prior, Ph.D., CEO of Innovate, stated, “We believe that during 2018 we have laid the foundation for an exciting 2019 by completing much of the preparatory work to launch our Phase 3 trial for celiac disease and to expand our pipeline in areas of liver disease.” Dr Prior added, “We are continuing our efforts to secure financing for this trial on favorable terms with the goal of benefiting our stockholders and bringing important medicines to patients where there are no currently available therapies.”

As previously presented, larazotide demonstrated decreased deterioration of gut permeability, in the DIAMOND NASH mouse model, where leaky gut developed by 16 weeks. With ongoing work in drug combinations with Novo Nordisk A/S’s OZEMPIC^® (semaglutide) approved for type 2 diabetes and Intercept Pharmaceuticals Inc.’s OCALIVA^® (obeticholic acid) approved for primary biliary cholangitis (PBC), Innovate expects to release data by EASL 2019.

Click here to read the full press release.