Humanigen (NASDAQ:HGEN) reported positive interim results from its Phase 3 trial evaluating lenzilumab in hospitalized COVID-19 patients.
Lenzilumab is an antibody that targets granulocyte-macrophage colony-stimulating factor, a central player in the inflammatory cascade.
The trial has enrolled 300 patients to-date. The interim analysis for sizing and powering suggests that lenzilumab had a clinically meaningful impact on patient recovery, with some 37% more recoveries observed in patients receiving lenzilumab, compared with those receiving the current standard-of-care.
At the data safety monitoring board’s (DSMB) recommendation, Humanigen plans to increase enrollment to some 515 patients to increase the target number of recoveries to 402, from 257.
“Based on this feedback from the DSMB, we believe the Phase 3 trial is significantly de-risked,” Dale Chappell, M.D., Humanigen’s CSO, said in a statement.
“Targeting 402 events improves the probability of success, maintains the power of the study at 90%, and further supports our plans for emergency use authorization and BLA submission,” he added.
Humanigen plans to file for emergency use authorization in the first quarter of 2021, following either interim data at 75% or at study completion.