CytoDyn Inc (OTCMKTS:CYDY) stock soared Tuesday as investors focused on its lead drug leronlimab in the Non-Alcoholic Steatohepatitis (NASH) space after CymaBay Therapeutics Inc’s (NASDAQ:CBAY) drug seladelpar posted disappointing results in a mid-stage clinical trial linked to NASH.
NASH is liver inflammation and damage caused by a buildup of fat in the liver. Patients with this disease are often told they have a "fatty liver."
Last month, Vancouver, Washington-based CytoDyn said that the Cleveland Clinic will test its flagship drug leronlimab (PRO 14O) to determine if it can prevent NASH in mice.
The goal of CytoDyn’s 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.
In a separate development, Newark, California-based CymaBay which had enrolled 181 patients with moderate NASH, and treated them for 12 weeks, suffered a setback.
In CymaBay’s Phase 2 study, three oral doses of seladelpar, all performed worse than a harmless placebo, based on a non-invasive imaging test that measures decreases in liver fat.
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.
Contact Uttara Choudhury at [email protected]