CytoDyn Initiates Phase 2 Clinical Trial with Leronlimab for Treatment of NASH (Non-Alcoholic Steato-Hepatitis); Preclinical Results Demonstrated Leronlimab Effectively Inhibited Fatty Liver Development

On June 11, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced 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 CytoDyn’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating non-alcoholic fatty liver disease (NAFLD), a common precursor to non-alcoholic 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 2020. 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 NASH. Nader Pourhassan, PhD, 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 trial 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.
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