Antibody for the Treatment of Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Application

Repurposed monoclonal antibody (mAb) that blocks inflammatory CD4 T cell migration for the treatment of NASH and liver fibrosis.

Key Benefits

  • Therapy for treating NASH, NAFLD, and liver fibrosis.
  • Potential reduced approval time due to existing clinical safety data for α4β7 mAb.

Market Summary

Non-alcoholic steatohepatitis (NASH) is a non-alcoholic fatty liver disease. Many of the patients with NASH further progress to cirrhosis, portal hypertension, and ultimately hepatocellular carcinoma. The growing obesity and diabetes rate throughout the world are increasing the cases of non-alcoholic steatohepatitis (NASH). NASH is one of the leading causes of liver transplant. Despite such a high prevalence and the severity of the disease there is currently no FDA approved drug for treating NASH.

Technical Summary

Emory researchers have recently demonstrated that the monoclonal antibody, Vedolizumab, would be an excellent treatment option for patients with NASH. The pre-clinical data demonstrate that integrin α4β7 mAb mediated blocking of inflammatory CD4 T cell infiltration in the liver and intestinal mucosa. α4β7 mAb is a potentially promising approach to treat NAFLD, NASH and liver fibrosis. Integrin α4β7 mAb has been tested in several clinical trials and shown to be safe in patients. The availability of clinical safety data will significantly reduce the approval time to repurpose α4β7 mAb for the treatment of NAFLD, NASH and liver fibrosis.

Developmental Stage

Preclinical in vivo studies.

Patent Information

App Type Country Serial No. Patent No. File Date Issued Date Patent Status
PCT PCT PCT/US2018/064191   12/6/2018   National Phase Entered
Tech ID: 17155
Published: 6/24/2019