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CytoDyn says first patient enrolled for its Phase 2 clinical trial using leronlimab to treat NASH

Published: 16:55 02 Dec 2020 EST

liver
The 60-patient, multi-center, double-blind, placebo-controlled Phase 2 two-arm study will assess the efficacy of leronlimab in adult patients with NASH, which is one of the most common reason for a liver transplant

CytoDyn Inc (OTCQB:CYDY) announced Wednesday that the first patient has been enrolled for its Phase 2 clinical trial for the treatment of non-alcoholic steatohepatitis (NASH) with Vyrologix (leronlimab-PRO 140). 

The Vancouver, Washington-based company's Phase 2 trial is designed to test whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. 

As previously reported, the company’s pre-clinical study demonstrated strong positive data highlighting the potential of leronlimab in treating non-alcoholic fatty liver disease (NAFLD), a common precursor to NASH. It said the inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis. 

READ: CytoDyn enlists 293 patients for second interim analysis of leronlimab in Phase 3 COVID-19 trial

NAFLD has become the most common cause of chronic liver disease in adults worldwide. And there are currently no US Food and Drug Administration (FDA) approved treatments for NASH, and it is expected to be the number one cause of liver transplants in 2020.  About 30% to 40% of adults in the US are living with NAFLD, and 3% to 12% are living with NASH.

The company said the trial 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,” said Dr Chris Recknor, vice president of clinical development at CytoDyn, in a statement. “The precision of this testing will optimize the success for showing CCR5 inhibition can improve NASH and NALFD.”

CEO Nader Pourhassan said the company is 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,”  Pourhassan said. “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 UK, Canada, and the US.”

The CEO added: “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.” 

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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