CytoDyn Inc (OTCMKTS:CYDY) announced Thursday that two coronavirus patients have been treated with its investigational new drug leronlimab.
In a statement, the group said the treatment was administered at a leading medical center in the New York City area under the emergency Investigational New Drug (IND) order recently granted by the US Food and Drug Administration.
Leronlimab is intended to serve as a therapy for patients who experience respiratory illness as a result of contracting the coronavirus disease (COVID-19).
READ: CytoDyn files modified IND and protocol for Phase 2 clinical trial of leronlimab to treat coronavirus respiratory symptoms
CytoDyn said the treatment was not under the company’s proposed randomized controlled Phase 2 clinical trial protocol recently submitted to the FDA.
“Leronlimab binds to the CCR5 receptor inhibiting the migration of macrophages and the release on inflammatory cytokines including TNF and IL-6. This release of cytokines is what is commonly referred to as the 'cytokine storm' and is believed to cause profound damage in the lungs in some patients,” said Dr Bruce Patterson, CEO of IncellDX and advisor to CytoDyn.
“In addition, leronlimab can block Regulatory T cells (Tregs), which can inhibit the innate immune response against pathogens, into areas of inflammation. These combined mechanisms of action may reduce the morbidity and mortality in moderate to severe cases of COVID-19, preventing the acute respiratory distress syndrome associated with this highly destructive and potentially fatal disease.”
CytoDyn CEO Nader Pourhassan stressed that leronlimab does not kill the novel coronavirus.
“It acts as a CCR5 antagonist by blocking pro-inflammatory cytokines, which prevents cytokine storm and thus could be useful in the treatment of COVID-19," he said.
Leronlimab, which is administered as a once-a-week injection, has a strong safety profile demonstrated in nine clinical trials with over 800 people and is available for urgent treatment, Pourhassan said.
He added: “If results are promising, we have leronlimab available for immediate use and the ability to scale production. We are open and willing to work with government agencies and pharmaceutical partnerships to assist in serving those in dire need of a treatment option for this devastating disease. We appreciate the FDA’s prompt response and are working in full support of the treating medical team.”
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