Innovate Biopharmaceuticals Inc. will collaborate with a researcher at the University of Maryland School of Medicine to develop larazotide as a potential treatment for diseases that affect the intestinal barrier, the company announced.
The intestine is composed of a layer of cells normally held tightly together to stop any foreign organisms from breaking the intestinal barrier. However, the permeability of the intestinal barrier can sometimes be compromised, leading to the development of intestinal diseases. This has led researchers to look for treatments that target intestinal permeability.
Innovate’s lead therapy candidate, larazotide acetate, also known as INN-2o2, is a regulator of these cell-cell boundaries, called junctions, and helps restore open or leaky junctions to a normal state.
The company is partnering with O. Colin Stine, PhD, a professor of epidemiology and public health at the University of Maryland, who has focused extensively on studying the molecular mechanisms that lead to bacterial invasion of the intestinal barrier as a result of increased intestinal permeability.
“Larazotide is the only known molecule in late stage clinical trials that decreases intestinal permeability,” Stine said in a press release.
The microbiota of the intestine — which includes bacteria and other microorganisms — regulates the permeability of the intestinal barrier. Several intestinal diseases including autoimmune and inflammatory diseases such as celiac disease, non-alcoholic steatohepatitis, and inflammatory bowel diseases have altered microbiota.
Research done by Stine’s lab, and several others, has shed light on how important it is to correct a damaged intestinal barrier and the dysfunctional microbiota that is pervasive in intestinal diseases.
In fact, the role of the intestinal barrier and irregular microbiome is increasingly being recognized in a range of diseases, including environmental enteric dysfunction, autoimmune diseases, metabolic diseases, and cancer.
“We believe intestinal barrier function compromised by dysbiosis [dysregulation of microbiota] can be restored by larazotide and this mechanism of action has the potential to provide tremendous clinical benefit.” said Chris Prior, PhD, Innovate’s CEO.
Stine has also conducted significant research into the mechanisms that lead to the development of intestinal diseases in children in developing countries. In particular, he led a study comparing the bacterial population in children who had diarrhea with children who did not.
“The mechanisms responsible for maintenance and restoration of the intestinal barrier should be the same whether the inflammation manifests as diarrhea and/or stunting in children from low-income countries or in adults suffering from intestinal ischemia/reperfusion injuries, inflammatory bowel diseases and celiac disease. Larazotide could play a significant role in this restoration process,” Stine said.
Larazotide has been granted fast track designation from the U.S. Food and Drug Administration for the treatment of celiac disease, and is entering Phase 3 trials for that indication.