Alba Therapeutics Corporation announced today the positive results of their Phase IIb trial evaluating its investigational product, larazotide acetate, a first-in-class tight junction regulator, intended for the treatment of patients with celiac disease (CeD). The study met its primary endpoint and, based on these results, Alba has 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% 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, diarrhea, 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. People with celiac disease who are exposed to gluten experience an immune reaction in their small intestines, causing damage to the inner surface (villi) of the small intestine, and an inability to absorb certain nutrients. Larazotide acetate has a novel mechanism of action that may help inhibit this immune reaction.
"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 program and look forward to advancing its development."
Alba Therapeutics Corporation