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

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 a presentation of the results from the Company’s randomized, double-blind, placebo-controlled LIVE-AIR Phase 3 study at IDWeek 2021, which is the joint annual meeting of the IDSA, the Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP) taking place virtually from September 29^th to October 3^rd.

Zelalem Temesgen, MD, Professor of Medicine at Mayo Clinic and Principal Investigator of the LIVE-AIR Phase 3 trial, will deliver a presentation regarding the efficacy and safety of lenzilumab in hospitalized COVID-19 patients at the meeting. The abstract (Number 1071804) entitled: “Lenzilumab Efficacy and Safety in Hospitalized COVID-19 Subjects: Results from a Phase 3 Randomized Double-Blind Placebo-Controlled Trial” has been accepted for oral presentation. The presentation will be available to participants throughout IDWeek 2021.

“As the principal investigator of the LIVE-AIR Phase 3 study, I am excited to share these data with the scientific community at IDWeek,” said Zelalem Temesgen, MD, Professor of Medicine at Mayo Clinic. “These results support the proposition that lenzilumab may be a foundational therapy to prevent the hyperinflammatory immune response which can lead to mechanical ventilation and ultimately death in hospitalized COVID-19 patients.”

The LIVE-AIR study achieved its primary endpoint of survival without ventilation measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.0403). Survival without ventilation is an important clinical endpoint that measures not only mortality, but the morbidity associated with mechanical ventilation. The Kaplan-Meier estimate for IMV and/or death was 15.6% (95%CI: 11.5-20.9) in the lenzilumab arm versus 22.1% (95%CI: 17.4-27.9) in the placebo arm. Approximately 94% of patients received dexamethasone (or other steroids), 72% received remdesivir, and 69% received both. In the subgroup of patients treated with both remdesivir and corticosteroids, lenzilumab improved survival without ventilation relative to placebo (HR: 1.92; 95%CI: 1.20-3.07, p=0.0067). In this study, lenzilumab appeared to be safe and well-tolerated, there were no serious adverse events (SAEs) attributed to lenzilumab and no suspected unexpected serious adverse reactions (SUSARS) reported for lenzilumab.