Promising Phase II Results for Difficult-to-Treat Liver Diseases


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CytoDyn shared the positive results of its Phase II clinical study on efficacy of leronlimab against non-alcoholic steatohepatitis (NASH).

The NASH assay met the primary endpoint of proton density fat fraction (PDFF) and the secondary endpoint of cT1. PDFF is an MRI-derived biomarker for fatty deposits, while cT1 is an iron-corrected T1 mapping indicator of liver fibrosis and inflammation. Both endpoints were used to assess the risk of NASH.

Participants received leronlimab each week during the two-part NASH trial. Part I observed a weekly dose of 700 mg versus a double-blind, randomized placebo. Part II looked at a weekly dose of 350 mg versus placebo in an open label study. The first results should be announced soon. Researchers found statistically significant improvement in the 350 mg dose group for both primary and secondary endpoints.

NASH is a chronic liver disease characterized by liver inflammation and hepatocellular bloating (cell damage). This is due to the accumulation of hepatic fat, also called steatosis, which is equal to or greater than 5% of hepatocytes. Even without excessive alcohol consumption, lack of physical activity and unhealthy eating habits can lead to this disease. If left untreated, NASH can progress to end-stage liver disease, cirrhosis, and hepatocellular carcinoma.

In the United States, about 30-40% of adults are diagnosed with non-alcoholic fatty liver disease (NAFLD), while 3-12% live with NASH. The Phase II NASH trial is investigating 22 different indications for solid tumor cancer.

“We are currently analyzing biomarker data including information on the CCR5 haplotype to better understand response rates and mechanism of action. Given that 5% of the world’s population is estimated to have NASH with 20% progressing to cirrhosis, this signal gives hope for therapeutic intervention for this disease, ”said Dr. Christopher P. Recknor, vice president senior executive of clinical operations at CytoDyn, in a statement.

Currently, there is no approved pharmacological treatment for NASH. The available therapies focus primarily on treating co-morbidities, including type 2 diabetes, cardiovascular disease, and obesity. Other NASH interventions also focus on lifestyle changes and improved diet.

Leronlimab is a humanized IgG4 mAb that works by binding to CCR5. It has a United States Fast Track designation Food and drug administration for metastatic cancer, especially triple negative breast cancer (mTNBC) and human immunodeficiency virus (HIV). For HIV, leronlimab is combined with HAART.

After seeking approval in the United States, CytoDyn reportedly intends to seek approval in Brazil, Canada, the Philippines and the United Kingdom as well.

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