Alba Therapeutics Corporation, a privately held, clinical-stage biopharmaceutical company, announced positive results of  phase IIb trial evaluating its investigational product, larazotide acetate, a first-in-class tight junction regulator, which is intended for treatment of patients with celiac disease (CeD) has met its primary endpoint and, based on these results, the company also initiated planning for phase III clinical trials for the definitive assessment of the oral peptide’s efficacy and safety.

The final data will be submitted for publication in the near future.

The double-blind, placebo-controlled study evaluated the efficacy and safety of larazotide acetate in the treatment of 342 patients with CeD who had persistent symptoms despite being on a gluten-free diet.

This is the seventh study in a broad clinical trial program for larazotide acetate that, to date, has included 828 patients with CeD. Larazotide acetate has been granted "Fast Track" designation from the FDA.

“Tight junction regulators represent a paradigm shift in the treatment of immune mediated and inflammatory disorders such as CeD. Recently published data suggest 70 per cent of patients continue to be exposed to gluten while on a gluten-free diet, highlighting the need for additional treatments for patients with celiac disease,” said Joseph A Murray, MD, the phase IIb study’s lead investigator and a gastroenterologist at the Mayo Clinic. “These promising trial results contribute to a growing body of data supporting the development of larazotide acetate, and the medical community looks forward to its continued development in an effort to provide an option to patients who struggle to manage the disease through diet alone.”

Celiac disease is an autoimmune disorder that is triggered by the ingestion of gluten, which is primarily found in bread, pasta, cookies, pizza crust and other foods containing wheat, barley or rye. Signs and symptoms of celiac disease include abdominal pain and cramping, bloating, diarrhoea, gas and failure to thrive (infants and small children). Celiac disease has also been associated with a heightened risk of cancer, including cancers of the esophagus, small and large intestines and T-cell lymphoma.

“There is a high unmet medical need for CeD as many patients are experiencing painful and often debilitating symptoms despite following a gluten-free diet,” said Wendy Perrow, MBA, chief executive officer of Alba. “We are very encouraged by the data observed in this phase IIb study as well as the other studies in the larazotide acetate programme and look forward to advancing its development.”

Larazotide acetate, Alba's leading product candidate for CeD, is a novel agent that belongs to a new class of drug called tight junction regulators. Tight junctions, which are located in the bowel, should remain closed except to shed dead cells. However, in patients with CeD, the presence of gluten causes the tight junctions to remain open, thus starting an inflammatory cascade within the bowel that eventually destroys the intestinal villa. Early research suggests larazotide acetate may help keep the tight junctions closed when ingested prior to a meal, thus reducing the inflammatory process in response to gluten.

Alba Therapeutics Corporation is a privately held, clinical-stage biopharmaceutical company focused on the development and commercialization of pharmaceutical products to treat celiac disease and inflammatory diseases.