Humanigen Inc (OTCQB:HGEN) announced Wednesday that the US Food and Drug Administration has given it permission to commence a Phase III study of lenzilumab in patients with coronavirus (COVID-19).
The Burlingame, California-based company's lead drug is aimed at treating so-called cytokine storm, which can lead to acute respiratory distress syndrome in COVID-19 patients.
Humanigen plans to enroll patients in a multicenter, randomized, placebo-controlled, double-blinded clinical trial with lenzilumab for the prevention of respiratory failure and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection.
READ: Humanigen poised to partner with leading contract research organization on Phase III trial to tackle deadly coronavirus
"We are working with some of the top centers and clinicians in the US, alongside our contract research organization partner, CTI, to bring lenzilumab rapidly through this clinical study which, if successful, may reduce serious and potentially fatal outcomes in patients hospitalized with COVID-19 and at high risk of progression," said Humanigen CEO Dr Cameron Durrant in a statement.
"Lenzilumab has demonstrated an excellent safety and tolerability profile in other disease settings, including severe asthma. As the only company that has been working on prevention of cytokine storm through GM-CSF neutralization for nearly three years, we have published extensively in this field and filed extensive IP. We plan to bring this experience to the COVID-19 setting and recruit patients into this Phase III study as quickly as possible."
Tim Schroeder, founder and CEO of CTI, praised the “exceptional level of collaboration between us and our counterparts at the FDA. Everyone is working extraordinarily hard to help bring treatments to patients, and we are proud to be a part of that effort."
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