Innovate Biopharmaceuticals of Raleigh has completed an agreement to license all of Alba Therapeutics’ assets relating to larazotide acetate, a drug candidate progressing toward phase three clinical trials for the treatment of celiac disease.

The compound, now named INN-202, has the potential to become the first approved medicine to treat celiac disease, an autoimmune disorder that affects three million people in the United States and about 15 million worldwide.

INN-202 has been granted a “fast track” designation by the U.S. Food and Drug Administration. Innovate said it would begin phase three clinical trials in late 2016.

Financial terms of the licensing agreement were not disclosed, but the deal includes up-front and milestone payments, according to a news release issued by Innovate.

“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, Ph.D., CEO of Innovate.

Innovate recently raised $2 million

Innovate, founded in 2012, is a privately held, clinical-stage biotechnology company focused on developing novel medicines for gastroenterological and orphan disorders. It recently raised $2 million from angel investors and will seek $4 million more in the near future, the company said.

The larazotide acetate license expands Innovate’s pipeline of gastrointestinal drug candidates. Other products in clinical development include a phase two-ready compound called INN-108 that is indicated for mild to moderate ulcerative colitis and another orphan gastrointestinal indication.

Drug candidate shows promise in clinical trials

Larazotide acetate, INN-202, is a novel oral peptide that has reduced symptoms of celiac disease in multiple clinical trials involving more than 800 patients. The latest trial, a phase two-b multi-center trial, evaluated the efficacy, safety and tolerability of larazotide acetate in 342 patients.

Alba Therapeutics, a privately held biopharmaceutical company based in Baltimore, has worked with the celiac disease patient community and gastroenterology physicians for the last 10 years to research and develop larazotide acetate, said Wendy Perrow, the company’s CEO.

“We are so excited to reach an agreement with Innovate which focuses on gastrointestinal product development and thrilled they will continue the ongoing research for patients with celiac disease,” Perrow said.

To be first phase three celiac trials

Daniel Leffler, M.D., director of research at the Celiac Center at Beth Israel Deaconess Medical Center in Boston, welcomed the licensing agreement on behalf of celiac patients and their families.

“There is a huge demand for adjunctive therapies from the celiac patient community,” he said, “and I am happy to see larazotide acetate moving ahead with what will be the first phase three trials ever conducted in celiac disease.”

Larazotide acetate is a novel agent that belongs to a new class of drugs called tight junction regulators. Tight junctions, located in the bowel, should remain closed except to shed dead cells.

However, in patients with celiac disease, the presence of gluten – a protein in certain foods such as wheat – causes the tight junctions to remain open, starting an inflammatory cascade within the bowel that eventually destroys the inner lining, or villi, of the small intestine.

Early research suggests larazotide acetate may help keep the tight junctions closed when ingested prior to a meal, reducing the inflammatory process in response to gluten.

Gluten is primarily found in bread, pasta, cookies, pizza crust and other foods containing wheat, barley or rye.

Gluten causes immune reaction in gut

People with celiac disease who are exposed to gluten experience an immune reaction in their small intestines, causing damage to the inner lining and an inability to absorb certain nutrients. Signs and symptoms of celiac disease include intestinal pain, bloating, diarrhea and – in infants and small children – failure to thrive.

These symptoms can be reduced, and sometimes eliminated, by avoiding food that contains gluten. However, many patients remain symptomatic despite a gluten-free diet and may benefit from drug therapy. Currently, there are no drugs available to treat celiac disease.

(C) N.C. Biotechnology Center