Interim data suggest clinically meaningful impact on patient recovery from COVID-19 with an estimated 37 percent more recoveries observed in lenzilumab arm of Phase 3 trial versus current standard of care
Data safety monitoring board recommendation demonstrates the Phase 3 trial is in the “promising zone” of the adaptive trial design
CRADA between Humanigen and U.S. government provides for regulatory and other support to submit an EUA and BLA
#HGEN "announced positive interim Phase 3 data of lenzilumab in patients hospitalized with COVID-19. This interim analysis for sizing and powering suggests that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37 percent more recoveries observed in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study versus current standard of care (SOC)".
Interim Phase 3 lenzilumab in COVID-19 data analysis highlights:
78 percent of trial participants on either remdesivir or dexamethasone (or other steroids) or both (across both arms of the study)
65 percent of trial participants with oxygen saturation ≤94 percent or on low-flow oxygen support
35 percent of trial participants on high-flow oxygen or non-invasive positive pressure ventilation at time of enrollment
45 percent of trial participants were 65 years of age or older
50 percent of trial participants from diverse populations
No serious adverse events have been attributed to lenzilumab
These findings apply across both arms of the study
See our HGEN AmpCard to learn more.