CytoDyn Initiates Phase 2 Clinical Trial With Leronlimab for Treatment of NASH
Preclinical results demonstrated leronlimab effectively inhibited fatty liver development
VANCOUVER, Washington, June 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today initiation of the Company’s Phase 2 clinical trial for the treatment of non-alcoholic steatohepatitis (NASH). The Phase 2 trial is designed to test whether leronlimab may control the devastating liver fibrosis associated with NASH.
As previously reported, the Company’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to nonalcoholic steatohepatitis (NASH). These data, along with previous findings showing that leronlimab inhibits liver fibrosis, suggests the potential of leronlimab to control both the early and late stages of NASH.
There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH and it is expected to be the number one cause of liver transplant by 20201. About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH2.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are excited to continue to advance the evaluation of leronlimab for a potential therapeutic benefit for NASH, a disease with an increasing prevalence in the U.S. Our strategic plan to execute a multi-pathway approach to exploring all potential benefits of leronlimab has led to cancer, COVID-19 and now potentially NASH, along with other immunologic indications.”
This is a 90-patient, multi-center, randomized, double blind, placebo-controlled Phase 2 three-arm study of the safety and efficacy of leronlimab in adult patients with NASH. NASH is a chronic liver disease characterized histologically by the presence of hepatic inflammation and cell injury due to hepatic fat accumulation (steatosis) equal or superior to 5% of hepatocytes. NASH develops in the absence of excessive alcohol consumption but is linked to unhealthy eating habits and lack of physical activity.