Humanigen Announces Oral Presentation of Lenzilumab LIVE-AIR Phase 3 Study Results at IDWeek 2021 - Seite 2

“We are pleased the phase 3 LIVE-AIR data have been selected for oral presentation at the most prestigious infectious disease meeting of the year,” said Cameron Durrant, CEO of Humanigen. “At Humanigen, we are committed to helping patients survive COVID-19 and believe that the clinical results seen with lenzilumab show its potential. There are 73,000 patients currently hospitalized in the U.S who have limited treatment options available to them.”¹

Humanigen once again thanks the investigators and patients in the LIVE-AIR study who helped to advance the development of lenzilumab and enable the achievement of this important milestone for the company.

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 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 invasive mechanical ventilation (IMV), which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.

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 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 endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 following treatment. Results of the trial have been submitted for publication in a peer-reviewed journal.