Humanigen Inc (OTCMKTS:HGEN) has moved a step closer in its plans to start a Phase III clinical trial for its lenzilumab antibidy to help coronavirus patients, namely submitting an initial protocol synopsis to the US Food and Drug Administration (FDA).
As reported last week, the biotech's monoclonal antibody lenzilumab is aimed at treating so-called cytokine storm, which can lead to acute respiratory distress syndrome (ARDS) associated with the current pandemic.
Humanigen planning Phase III clinical trial for lenzilumab to treat coronavirus patients; shares soar
There are now over 542,000 confirmed cases of coronavirus (COVID-19) globally and over 24,000 deaths.
Patients with the severe form of the disease experience viral pneumonia that can progress to ARDS and death.
A rapid escalation in ARDS presents a major challenge for health systems around the world given limited hospital beds and ventilators.
"Humanigen has pioneered the field of GM-CSF neutralization and, unlike others, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results," said Dr Cameron Durrant, chief executive of Humanigen.
"We have been working on prevention of cytokine storm for nearly three years. Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events, including in patients who are immunosuppressed or with severe asthma.
"Subject to discussion and agreement with regulatory authorities, we intend to progress as quickly as possible with this study," the company boss added.
Humanigen's clinical study, if approved, will be a muti-centre, US, randomized, controlled, clinical trial with lenzilumab.
Shares in New York ticked up 4.6% to $1.35 each.
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