viewCytoDyn Inc.

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

The 60-person trial will test the efficacy and safety of leronlimab versus placebo at controlling liver damage associated with the chronic disease

Doctor holing a model liver
NASH is characterized by the buildup of liver fat, which causes inflammation and cell injury

CytoDyn Inc (OTCMKTS:CYDY) has received clearance from the US Food and Drug Administration to begin enrollment of a Phase 2 clinical trial of its flagship drug leronlimab for the treatment of non-alcoholic steatohepatitis (NASH). 

The 60-person trial will test the efficacy and safety of leronlimab against a placebo at controlling the liver damage associated with the chronic disease. 

NASH, also referred to as metabolic disease of the liver, is characterized by the buildup of liver fat, which causes inflammation and cell injury. It develops without excessive alcohol consumption.

READ: CytoDyn's triple-negative breast cancer drug leronlimab given to first patient in clinical trial

Leronlimab works by blocking CCR5, a cellular receptor important in HIV infection, tumor metastasis and other diseases including NASH. 

“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,” CEO Nader Pourhassan said in a statement. “We again thank the men and women who have agreed to participate in our trials.”

Treatment of NASH is just one of leronlimab’s potential applications. The drug has already been awarded FDA Fast Track designation for use as part of a combination therapy in patients with HIV and for the treatment of triple-negative metastatic breast cancer.

Shares of CytoDyn rose 1.9% Wednesday to $0.36.

—Updated to include stock movement—

Contact Andrew Kessel at [email protected] 

Follow him on Twitter @andrew_kessel

Quick facts: CytoDyn Inc.

Price: 4.81 USD

Market: OTCQB
Market Cap: $2.5 billion

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