Innovate Biopharmaceuticals Teams Up With CRO for Phase III Celiac Trial

Shares of Innovate Biopharmaceuticals are up more than 7 percent in premarket trading after the company announced it signed an agreement with privately-held Amarex Clinical Research to provide data management and biostatistics for its planned Phase III celiac disease trial.

Amarex, Innovate announced this morning, will provide the company with electronic data capture solutions and associated services for data management and biostatistics.

June Almenoff, chief medical and chief operating officer of North Carolina-based Innovate, said Amarex has a strong reputation for its expertise in biostatistics and data management.

“I am pleased to be working with Amarex to support our Phase III trial. Our clinical team has been impressed with Amarex's capabilities, and we look forward to a productive working relationship,” Almenoff said in a statement.

Innovate is investigating larazotide acetate as a treatment for celiac disease. The company said larazotide is the “only drug which has successfully met its primary endpoint with statistical significance” in a Phase IIb trial. For celiac patients, larazotide acetate “renormalizes the dysfunctional intestinal barrier” through a mechanism that decreases intestinal permeability, which is sometimes referred to as “leaky gut.” It also reduces antigen trafficking, such as gliadin fragments in celiac disease, according to data provided by Innovate. Larazotide acetate could also potentially prove to be a treatment for other disorders, including NASH (nonalcoholic steatohepatitis), Crohn's disease, ulcerative colitis, irritable bowel syndrome, type 1 diabetes mellitus chronic kidney disease.

Celiac disease is an autoimmune disorder that causes about one in 100 people to have a negative reaction to the ingestion of gluten. When gluten is eaten by people with celiac disease, their body’s immune system responds with an attack on the small intestine.

Earlier this summer, Innovate presented data at the Digestive Disease Week conference that showed larazotide acetate “stimulates recovery of ischemic-injured intestine in a dose-dependent manner associated with restoration of tight junctions.”

That trial concluded at the end of 2017 and Innovate has been meeting with the U.S. Food and Drug Administration about its Phase III trial. That late-stage trial will begin later in 2018, the company said. Larazotide has received Fast Track designation from the FDA for celiac disease.

“We are excited to support Innovate in the development of its novel therapeutic, which has the potential to help so many patients suffering from celiac disease. We look forward to working closely with Innovate's experienced team to advance the clinical development of larazotide for this underserved population,” Kazem Kazempour, president and chief executive officer of Amarex said in a statement.