Humanigen Submits All Planned Modules for Potential Conditional Marketing Authorization from the UK’s MHRA

Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced it has submitted all the planned modules as well as a risk management plan and pediatric investigation plan for the lenzilumab Conditional Marketing Authorization (CMA) in hospitalized COVID-19 patients to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA has previously accepted the application for expedited COVID-19 rolling review.

“We are pleased with the engagement with MHRA and are committed to continue to work with the agency as necessary to enable MHRA to review our application. As the United Kingdom’s Health Secretary recently stated, the UK is leading the world in identifying and rolling out life-saving medicines, particularly for COVID-19,”¹ said Cameron Durrant, CEO of Humanigen. “A UK study funded by the Medical Research Council demonstrated benefits of GM-CSF neutralization in hospitalized COVID-19 patients and we believe results of our LIVE-AIR Phase 3 trial of lenzilumab provide further evidence for the benefits of this approach. Thus, we are seeking Conditional Marketing Authorization with a view to bringing lenzilumab to patients in the UK. We note in the UK there have been more than 20,000 new hospitalizations in the month of September and as of September 27^th there were 7,007 people currently hospitalized for COVID-19.”^2,3

About the LIVE-AIR, Phase 3 Study of Lenzilumab

This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia. The LIVE-AIR study enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation; and were hospitalized but did not require invasive mechanical ventilation (IMV). Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, with each infusion separated by eight hours over a 24-hour period. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated ‘cytokine storm’ and improve survival without ventilation, or ‘SWOV’ (sometimes referred to as ‘ventilator-free survival’). SWOV is a composite endpoint of time to death and time to IMV, which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation. SWOV is an important clinical endpoint that measures not only mortality, but the morbidity associated with mechanical ventilation.