Innovate Biopharma's lead drug candidate, larazotide acetate (INN-202), is a novel oral peptide with a unique mechanism of action that is expected to begin Phase 3 clinical trials in 2017 for celiac disease, an indication for which it has received Fast Track designation from the FDA. Larazotide modulates intestinal permeability and regulates tight junctions by reducing antigen trafficking across epithelial cells in the intestines. In clinical studies to date in more than 800 patients, larazotide has demonstrated clinically meaningful and statistically significant reduction in clinical symptoms of celiac disease, and has a highly favorable safety profile comparable to placebo, with no systemic exposure.
Innovate's second therapeutic, INN-108, is expected to enter Phase 2 trials in 2017. INN-108, a small molecule prodrug that only becomes activated in the colon, is being developed for the treatment of an adult orphan indication and for mild-to-moderate ulcerative colitis. An oral liquid formulation is also in development for pediatric and elderly patients.
Forward Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical development of our product candidates, which are subject to risks and uncertainties that could cause actual results to differ materially. Reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates; and risks of increased regulatory requirements, amongst others. These forward-looking statements speak only as of the date hereof. Innovate Biopharmaceuticals disclaims any obligation to update these forward-looking statements.
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SOURCE Innovate Biopharmaceuticals Inc.