Humanigen angling to go from zero to $1B with U.S., U.K. COVID-19 therapy filings

Humanigen could go from zero to $1 billion in sales if its COVID-19 treatment clears regulatory review in the U.S. and U.K., analysts from Cantor Fitzgerald said.

The self-described “cytokine storm company” filed a rolling submission in the U.K. Monday for authorization of lenzilumab to treat hospitalized COVID-19 patients. This follows a May 28 authorization filing to the FDA.

“We continue to think that [Humaingen]'s COVID-19 opportunity and the rest of its pipeline are underappreciated,” said Cantor’s note. “Despite vaccine uptake, there continues to be a need for proven therapies that are variant-agnostic for patients who remain at risk of COVID-19.”

The therapy could become a standard of care and bring in $1 billion in sales in the first 12 months, the firm estimated. Humanigen currently has no product sales.

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Lenzilumab’s submissions are supported by data from a phase 3 clinical trial called LIVE-AIR that found a 54% improvement in the likelihood of survival without ventilation among patients who received the therapy. When paired with corticosteroids and remdesivir, that improvement jumped to 92%. Patients did not suffer any adverse events, and lenzilumab's safety was comparable to placebo.

Humanigen met its goal of filing for FDA authorization by June. The company also wants to get the therapy cleared for a full approval, but the agency is likely to request more trials first.

While several therapies are available for certain COVID-19 patients, the field remains wide open for new ones that can help critically ill people. Virus variants have also put a strain on drug developers, sending Big Pharmas like Eli Lilly back to the drawing board shortly after gaining authorization for a remedy. 

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Lenzilumab targets GM-CSF, a cytokine associated with negative outcomes in COVID-19 patients. By neutralizing the cytokine, drug developers including Humanigen and GlaxoSmithKline figure they may be able to counter life-threatening complications that arise when the immune system reacts particularly strongly to the virus.

"Despite vaccine uptake, there continues to be a need for proven therapies that are variant-agnostic for patients that remain at risk of COVID-19," said Humanigen CEO Cameron Durrant. "Now, with applications in the U.S. and in the U.K., we feel we can help tackle this global challenge. We hope to provide a powerful solution for hospitalized patients on both sides of the Atlantic."

Humanigen's therapy is also under development for other conditions that involve cytokine storm, including acute graft-versus-host disease. Lenzilumab hit its primary goal in a phase 3 trial testing its ability to prevent or treat hyperinflammation or cytokine storm. A phase 2 study for the same indication is sponsored by the National Institutes of Health. 

Cytokine storm is an immune system overreaction that can result from an infection, autoimmune condition or disease. Research suggests COVID-19 causes this reaction, kicking the immune system into overdrive in severe cases.