Humanigen Inc (OTCMKTS:HGEN) said Thursday that the US Food and Drug Administration (FDA) has approved its key drug candidate lenzilumab being given to coronavirus (COVID-19) patients under individual patient emergency investigational new drug (IND) applications under the company's compassionate use program.
The Burlingame, California-based company is planning to conduct a multicenter, Phase III, double-blinded clinical trial with lenzilumab to reduce, or prevent so-called cytokine storm, which can lead to acute respiratory distress syndrome (ARDS) resulting from the coronavirus infection.
"We are gratified to be able to offer compassionate use of lenzilumab for patients with COVID-19. Humanigen has pioneered the field of GM-CSF neutralization and, unlike other GM-CSF approaches, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results," Humanigen CEO Cameron Durrant said in a statement.
READ: Humanigen moves a step closer to a Phase III trial to tackle leading cause of death in coronavirus
Lenzilumab has been shown to prevent cytokine storm in animal models and this work has been published in peer-reviewed publications.
Studies have shown that Lenzilumab, a recombinant monoclonal antibody neutralizes a substance that promotes growth of white blood cells but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects.
The Humanigen boss said lenzilumab has “an excellent safety and tolerability” profile and has not been associated with serious adverse events.
“Prior studies have included patients who are immunosuppressed, as well as patients with severe asthma. We have been working on prevention of cytokine storm for nearly three years,” Durrant pointed out.
“We have published extensively in this field, the mechanism of which has been subsequently reinforced by other companies following our lead in this area. In addition, we have filed extensive IP on GM-CSF neutralization across a wide range of therapeutic areas, including COVID-19," he added.
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