CytoDyn Inc (OTCMKTS:CYDY) revealed Wednesday that it has filed an Investigational New Drug (IND) application and a Phase 2 clinical trial protocol with the US Food and Drug Administration for its flagship drug leronlimab to treat patients with non-alcoholic steatohepatitis (NASH).
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."
In a statement, the Vancouver, Washington-based late-stage biotechnology company said leronlimab blocks CCR5, a cellular receptor, which has found to be important in HIV infection, tumor metastases, and NASH.
The company said that based on published reports of the involvement of CCR5 in the pathogenesis of nonalcoholic fatty liver disease, and following the company’s positive preclinical data, the Phase 2 trial is designed to test whether leronlimab can control "the devastating liver fibrosis" associated with NASH.
“We are cautiously optimistic about the potential of leronlimab to provide a new therapeutic option for individuals diagnosed with NASH. We again thank the men and women who have agreed to participate in our trials,” said CytoDyn CEO Nader Pourhassan in a statement.
The 60-patient, multi-center, randomized, double blind, placebo-controlled Phase 2 study is designed to test the safety and efficacy of leronlimab (PRO 140) in adult patients with NASH.
NASH develops in the absence of excessive alcohol consumption but is linked to unhealthy eating habits and lack of physical activity.
The IND program is the means by which a pharma company obtains permission to start human clinical trials and to ship an experimental drug across state lines usually to clinical investigators before a marketing application for the drug has been approved.
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