First Celiac Disease Medicine in Late-Stage Clinical Trials

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The First Ever Celiac Disease Medicine in Late-Stage Clinical Trials

Alba Therapeutics has announced that their celiac treatment, larazotide acetate, will enter the first Phase 3 clinical trials ever conducted in a celiac disease drug later this year.

“We are pleased to complete the agreement with Alba and are tremendously excited to start the final development of larazotide acetate for celiac disease, a high unmet medical need because the symptoms are painful and socially debilitating despite being on a gluten-free diet,” said Chris Prior, CEO of Innovate.

“For the past 10 years, Alba has been working diligently to research and develop larazotide acetate for patients who have celiac disease. The celiac disease patient community and their gastroenterology physicians have been instrumental to the success of our research and work in this field,” said Wendy Perrow, CEO of Alba.

“There is a huge demand for adjunctive therapies from the celiac patient community, and I am happy to see larazotide acetate moving ahead with what will be the first Phase 3 trials ever conducted in celiac disease,” said Dr. Daniel Leffler, director of research at The Celiac Center at Beth Israel Deaconess Medical Center.

Larazotide Acetate, now renamed INN-202 is an innovate drug that could improve symptoms for Celiac Disease. It is soon entering the phase 3 clinical trials. INN-202 is a tight junction regulator, therefore it restores open junctions in the gut to a normal state. As ingestion of gluten in CD patients causes the tight junctions to remain open, triggering an inflammatory cascade within the intestinal epithelium, that in the long run destroys the villi. When INN-202 is ingested prior to a meal, it may help keep the tight junctions closed, thus reducing the intestinal-inflammatory process in response to gluten.

Celiac Disease people only have the gluten-free diet to manage their symptoms. This would be first treatment besides the gluten-free diet. There are approximately 3 million Celiac patients in the US and the same number in Europe, with another 15 million in the rest of the world.

“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.”

If approved as announced, it will be the first prescription medicine in the world for treating celiac disease.




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