First patient dosed in FDA-Approved Phase III Lenzilumab study for COVID-19

Humanigen, a clinical-stage biopharmaceutical company, based in California, United States has announced that the first COVID-19 patient has been dosed in its previously announced Phase III study. The company is focused on treating patients with lenzilumab, the company’s proprietary humanized monoclonal antibody with the intent to prevent serious and potentially fatal outcomes in high-risk patients who are hospitalized with COVID-19.

Hyderabad: Humanigen, Inc., a clinical-stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary humanized granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, announced that the first COVID-19 patient has been dosed in its previously announced Phase III study.

“We are working with some of the top centres and clinicians in the US, alongside our contract research organization partner, CTI, to advance lenzilumab through Phase III with the intent to prevent serious and potentially fatal outcomes in high-risk patients who are hospitalized with COVID-19. We are encouraged by our experiences in the compassionate use patients treated with lenzilumab and look forward to working with stakeholders to share these data,” said Dr Cameron Durrant, chief executive officer of Humanigen.

“We are pleased with the speed with which this program has moved through FDA approval and site activation,” remarked Tim Schroeder, founder and CEO of CTI.

Dr Durrant said, "GM-CSF has been shown to be earlier in the cascade, or ‘upstream’, of multiple other cytokines, such as IL-6, IL-1 and TNF-α in a cytokine storm. Excess GM-CSF production is thought to be the key initial trigger in certain disease states that may lead to significant ‘downstream’ consequences, as these and other cytokines become elevated. Therefore, the possibility exists that the cytokine storm may be prevented or minimized by neutralizing GM-CSF."

"As the only company working on prevention of cytokine storm through GM-CSF neutralization for nearly three years, we have multiple accepted publications in this field, substantial safety data, including in patients with severe respiratory disease, and have filed extensive IP. We are grateful to FDA, CTI, other partners and our extensive network of recruitment centres in their support to enable recruitment of patients into this study as quickly as possible,” Dr Durrant added.