Larazotide Acetate or INN-202 is Innovate's leading drug candidate for Celiac Disease (CD) entering phase 3 clinical trials. INN-202 is a tight junction regulator, which helps restore “leaky” or open junctions to a normal state. In CD patients, ingestion of gluten causes the tight junctions to remain open. The open junctions cause an inflammatory cascade within the intestinal epithelium that eventually destroys the intestinal villa. Larazotide acetate, when ingested prior to a meal, may help keep the tight junctions closed, thus reducing the intestinal-inflammatory process in response to gluten.
Celiac Disease remains an unmet need with no drugs approved. Patients diagnosed with Celiac Disease only have the gluten-free diet to manage their symptoms. There are more than 3 million Celiac patients in the US and a similar number in Europe with another 15 million in the rest of the world.Larazotide would be the first drug ever approved for Celiac Disease by 2018.
Larazotide Acetate is the only late-stage drug entering phase 3 trials with a Path Forward agreed upon with the FDA regarding the primary endpoint, dose and phase 3 trial design. After several clinical trials involving more than 800 patients and a phase 2B trial with 342 patients, Larazotide has been shown to be safe and effective in a “real world setting” for Celiac patients. Phase 3 trials are expected to begin later in 2016.