CytoDyn’s positive preclinical data supports leronlimab as treatment for non-alcoholic fatty liver disease

CytoDyn Inc (OTCMKTS:CYDY) said Thursday that it had strong positive preclinical data highlighting the potential of its lead drug leronlimab as a treatment for non-alcoholic fatty liver disease (NAFLD), which is the accumulation of liver fat in people who drink little or no alcohol. 

In a statement, the Vancouver, Washington-based late-stage biotechnology company said NAFLD is a common precursor to non-alcoholic steatohepatitis (NASH). Again, NASH is a chronic liver disease characterized by liver inflammation and damage caused by a buildup of fat in the liver. Patients with this disease are often told they have a “fatty liver.” 

The data, along with previous findings show that leronlimab inhibits liver fibrosis, demonstrates the potential of leronlimab to control both the early and late stages of NASH, said the company.

READ: CytoDyn wins FDA clearance to begin Phase 2 trial of its drug leronlimab in patients with NASH

In the study, in which immunodeficient, NOD-scid gamma (NSG) mice were fed a high fat, NASH-inducing diet, transplanted with human stem cells to repopulate the deficient immune system, and treated with leronlimab, the investigators found that leronlimab inhibited fatty liver development, an early indication of NASH. CytoDyn previously published data showing that leronlimab completely blocked Xeno-GvHD in these humanized mice.

Dr Daniel Lindner of the Cleveland Clinic, who conducted the studies, said: “Our results showed that leronlimab effectively inhibited fatty liver development, the hallmark of early stages of NASH.”

CytoDyn is developing leronlimab (PRO 140) to battle multiple diseases. The company has filed an Investigational New Drug (IND) application and a Phase 2 clinical trial protocol with the US FDA for leronlimab to treat patients with non-alcoholic steatohepatitis (NASH). Leronlimab has also already completed nine clinical trials and been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event. CytoDyn is also exploring leronlimab’s use in the treatment of cancer, inflammatory conditions and autoimmune diseases.

“We are very excited to see more evidence showing that leronlimab may play a critical role in slowing or reversing disease progression in NAFLD and potentially NASH patients,” said CytoDyn CEO Nader Pourhassan.

“It is important to note that in people living with human immunodeficiency virus (HIV), the occurrence of NAFLD is higher than in the general population, affecting 30 to 65% of the HIV population. Medications that HIV patients take as part of their regimen may cause fatty liver development and have other hepatoxic effects. As we approach 1,000 patients involved in our HIV trials, we have not observed the hepatoxicity that has been evident in other CCR5 antagonists and HIV medications,” he added.

The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of HIV, which causes acquired immune deficiency syndrome (AIDS).  

“We see leronlimab as potentially anchoring a patient’s HIV treatment regimen, or as a monotherapy HIV drug, designed to protect the liver, maintain and regain liver health, and protect healthy cells from HIV entry,” said Dr Pourhassan.

There are currently no Food and Drug Administration-approved treatments for NASH and it is expected to be the number one cause of liver transplant by 2020. About 30-to-40% of adults in the US are living with NAFLD, and 3 to 12% of adults in the US are living with NASH.

“The significant unmet medical need and the lack of approved treatment options for NASH has led to a healthy interest in licensing therapeutics, even those in the preclinical phase,” said Brendan Rae, senior vice president of business development at CytoDyn Inc.

“Based on recent activity in the space, combined with leronlimab’s efficacy and human safety profile in the model, we expect there to be a significant interest from industry stakeholders in the development of leronlimab for the treatment of NASH.”

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors