Humanigen Inc has announced positive interim Phase 3 data of lenzilumab in patients hospitalized with Covid-19.
Humanigen is a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead investigational treatment lenzilumab.
According to the company, 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).
Cameron Durrant, chief executive officer of Humanigen, said, “These interim data demonstrate the potential of lenzilumab as a frontline treatment option for patients hospitalized with COVID-19.”
“We are encouraged by these data and the clinically meaningful impact that lenzilumab may have for patients with COVID-19 over and above remdesivir and/or steroids,” he added.
Data Safety Monitoring
DSMB (Data safety monitoring board) composed of independent subject matter experts carried out an interim analysis of the unblinded data for trial sizing and powering and recommended increasing the target number of events (recoveries) from 257 to 402 to maintain the power of the study at 90 percent.
The adaptive trial design only allows for the addition of patients if interim data are in the “promising zone” (i.e., achieving or surpassing an average improvement in recoveries of 29 percent (hazard ratio (HR) >1.29) through day 28).
The firm remains blinded to the data and based on the recommended number of events, the HR was calculated to be 1.37, an average of 37 percent more recoveries observed in the lenzilumab arm compared to the control arm.
It said that any observed benefit in the lenzilumab arm would be over and above the use of remdesivir and/or steroids which are among the treatments that have been used as SOC in both the lenzilumab treatment arm and the placebo arm of the study.
(With inputs from The OnLook News Research Bureau)