The goal of the exploratory pre-clinical studies by Dr. Daniel Linder is to establish leronlimab’s ability to prevent the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) into NASH, the Vancouver, Washington-based company said in a statement.
READ: CytoDyn secures fast track FDA designation for leronlimab in treating metastatic triple negative breast cancer
“A successful proof-of-concept study of leronlimab in NASH will allow the company to immediately file with the FDA an (investigational new drug program) and protocol for a Phase 2 trial,” said CEO Nader Pourhassan.
NAFLD is an inflammatory disease caused by the build-up of fat in the liver of people who drink little or no alcohol. In severe cases, NAFLD progresses into NASH. It is estimated that 30% to 40% of adults in the US have NAFLD, while 3% to 12% of adults in the US have NASH, the company said.
If left untreated, NASH can progress to more serious disease stages, such as advanced fibrosis, cirrhosis, liver failure or liver cancer. CytoDyn said the disease is expected to become the leading cause of liver transplants by 2020.
Despite the growing awareness of NASH, it remains difficult to diagnose and there are currently no therapies approved by the US Food and Drug Administration.
Meanwhile, the CCR5 pathway has been shown in multiple clinical trials and in unrelated third-party research to be a potential key target in NASH, and leronlimab is a highly selective CCR5 inhibitor, CytoDyn said.
Contact the author: [email protected]
Follow him on Twitter @PatrickMGraham