FOR IMMEDIATE RELEASE [Burlingame, CA and Covington, KY ~ March 30, 2020]– Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human-granulocyte-macrophage colony stimulating factor (GM-CSF) monoclonal antibody, announced that the company has submitted an initial protocol synopsis to the FDA in support of the company’s plans to initiate a multi-center, US, Phase III study in COVID-19 patients.
The study, if approved, will be a randomized, controlled, clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19. The study will be conducted in partnership with CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization specializing in complex programs for critically and chronically ill patients.
“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 officer 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 COVID-19 pandemic demands an unprecedented response from the pharmaceutical and biotechnology communities, requiring innovation, collaboration, and prioritization of speed without the cost of safety,” remarked Tim Schroeder, founder and CEO of CTI. "We are proud to have the opportunity to collaborate on such a response with the Humanigen team and to work together to develop an effective treatment solution for those hardest hit by COVID-19.”
More details on the company’s programs in COVID-19 can be found on the company’s website at www.humanigen.com under the COVID-19 tab.