Asana Medical has announced positive data from a preclinical study using an innovative liquid treatment called Extracellular Matrix Hydrogel (ECMH) for the treatment of ulcerative colitis (UC) and other gastrointestinal diseases.
The study, sponsored by Asana, was conducted in partnership with a team led by Dr. Stephen Badylak, MD, PhD, at the University of Pittsburgh’s McGowan Institute for Regenerative Medicine.
Published in the Journal of Crohn’s and Colitis, the study is titled “Restoring Mucosal Barrier Function and Modifying Macrophage Phenotype with an Extracellular Matrix Hydrogel: Potential Therapy for Ulcerative Colitis.”
The preclinical proof-of-concept showed that in an ulcerative colitis mouse model, the nonsurgical and non-pharmacologic ECMH-therapy promoted mucosal regeneration and inhibited inflammation. The therapy was also able to restore the epithelial barrier function, and to reduce stool blood and weight loss.
“The study results suggest an alternative to traditional therapies for inflammatory bowel disease,” Badylak, lead researcher at McGowan, said in a press release. “The study shows the ability of ECMH to rapidly transform the inflammatory flares of UC into a healing state in this rodent model. These findings are consistent with the known mechanisms by which ECM provides constructive signals in other body tissues.”
“Traditional therapy attempts to ameliorate clinical symptoms by reducing inflammation. This approach with ECMH seems to be to try to provide a local scaffold to allow healing,” added Dr. Steven Wexner MD, PhD (Hon), director of the Digestive Disease Center and chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida and current member of Asana’s Medical Advisory Board.
Asana will use the data from the study to support an application for regulatory approval to initiate a human clinical trial, expected to start in 2017, said Asana CEO Dr. Christine V. Sapan.
“Asana will now turn its focus on completion of the preclinical studies, manufacturing, and preparation of the regulatory filings,” Sapan said.
Intestinal fibrosis, commonly defined as excessive deposits of extracellular matrix (ECM) resulting from chronic inflammation and impairment of intestinal wound healing, represents a serious complication of inflammatory bowel diseases — both ulcerative colitis and Crohn’s disease.
Asana’s ECMH technology is a version of ECM, a major structural component of the human body, derived from natural animal tissue. ECM is delivered to the colon using a standard GI procedure, creating a drug-free, surgery-free therapy to facilitate disease remission. The company’s first target is ulcerative colitis, to be followed by Crohn’s disease and rectal mucositis.