CytoDyn kicks off Phase 2 trial of leronlimab as treatment for NASH

CytoDyn Inc (OTCQB:CYDY) announced the launch Friday of a Phase 2 clinical trial of its flagship drug leronlimab as a treatment for the liver condition non-alcoholic steatohepatitis (NASH). The 90-patient double-blind trial is designed to investigate whether leronlimab may control the liver fibrosis - the formation of large amounts of scar tissue - associated with the disease. Previously, a preclinical study showed leronlimab’s potential in treating nonalcoholic fatty liver disease (NAFLD), considered a common precursor to NASH. There are no drugs currently approved by the US Food and Drug Administration (FDA) to treat Nash, which is expected to be the leading cause of liver transplants this year, according to research published in the journal Visceral Medicine. READ: CytoDyn meets 75 patient enrollment for Phase 2 trial of leronlimab for patients with mild-to-moderate symptoms of COVID-19 The same article said that roughly 30%-40% of US adults are living with NAFLD and 3-12% are living with NASH. NASH is a chronic liver disease characterized by the presence of inflammation and cell injury due to fat accumulation in the liver. “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 US,” CytoDyn CEO Nader Pourhassan said in a statement. “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.” CytoDyn recently met its 75-patient enrollment target in its Phase 2 trial of leronlimab in mild-to-moderate coronavirus patients. Enrollment continues for its Phase 2b/3 trial for severe and critically ill cotonavirus patients.  Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel