CytoDyn Announces First Patient Enrolled in Phase 2 Trial for NASH
Preclinical results demonstrated leronlimab effectively inhibited fatty liver development
VANCOUVER, Washington, Dec. 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the first patient first visit metric was met for the Company’s Phase 2 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH). The Phase 2 trial is designed to test whether leronlimab may inhibit 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 NASH. Inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis.
Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide. 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 transplants in 2020.1 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.2
“NASH is found in 65% of HIV patients with chronic elevation of transaminases. HIV provides a window into a potential mechanism for fibrosis caused by CCR5 disease-promoting liver macrophages and hepatic stellate cells. This study is a 60-patient, multi-center, randomized, double-blind, placebo-controlled Phase 2 two-arm study to assess the efficacy of leronlimab in adult patients with NASH. The study uses advanced MRI technology to monitor fatty deposition via proton density fat fraction and fibrosis by CT1 analysis without invasive biopsy. The precision of this testing will optimize the success for showing CCR5 inhibition can improve NASH and NALFD,” said Chris Recknor, M.D., Vice President Clinical Development of CytoDyn.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are advancing all potential indications of leronlimab as fast as safely possible. We believe leronlimab will be an important part of many therapeutics including HIV, cancer and now NASH. We also hope to play a critical role in reducing mortality in patients infected with COVID-19. We hope to have a conference call toward the latter part of next week and update our shareholders with our progress and timelines for bringing leronlimab to market in the U.K., Canada, and the U.S. As a pre-revenue public company, we are always mindful of funding. With leronlimab’s many potential indications and finishing our quarter end with significant cash on hand, we believe we are well-positioned to move this Company forward. We look forward to our newly appointed Chief Scientific Officer, Mahboob Rahman, M.D., Ph.D., sharing our clinical advance timelines, who has an excellent track record of successful license applications with the FDA.”