Cytodyn has secured US Food and Drug Administration (FDA) clearance to begin patient enrolment in a Phase II clinical trial of leronlimab (PRO 140) to treat non-alcoholic steatohepatitis (NASH).
Investigational humanised IgG4 monoclonal antibody (mAb) leronlimab is designed to inhibit a cellular receptor known as CCR5, which is involved in HIV infection, tumour metastases, NASH and other diseases.
The drug received fast track designation from the FDA to treat HIV-infected patients in combination with highly active antiretroviral therapy (HAART), as well as for metastatic triple-negative breast cancer treatment.
It also holds FDA orphan drug status to prevent graft-versus-host disease (GvHD).
The new multi-centre, randomised, double-blind, placebo-controlled Phase II study is intended to evaluate the safety and efficacy of leronlimab in 60 adults with NASH.
The drug will be tested for its ability to control liver fibrosis caused by NASH.
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NASH is a common chronic liver disease that results in hepatic inflammation and cell injury. It can progress to cirrhosis, end-stage liver disease and hepatocellular carcinoma (HCC).
The condition currently lacks approved pharmacological therapies.
CytoDyn president and CEO Nader Pourhassan said: “Based on published reports of the involvement of CCR5 in the pathogenesis of NASH, and the company’s positive preclinical data, we are cautiously optimistic about the potential of leronlimab to provide a new therapeutic option for individuals diagnosed with NASH.”
Leronlimab has so far been assessed in more than 800 people across nine clinical trials.
In May, CytoDyn submitted the pivotal clinical trial protocol for leronlimab to the FDA. The Phase III trial will assess the treatment strategy and clinical safety of subcutaneous leronlimab in HIV-1 infected patients.