Humanigen said that lenzilumab has delivered a clinically meaningful impact on the recovery of patients hospitalized with Covid-19, as per the interim data of a phase 3 trial.
According to the US biopharma company, the interim analysis for sizing and powering, an estimated 37% more recoveries were seen in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study compared to current standard of care (SOC).
Cameron Durrant – CEO 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.”
The main goal of the phase 3 clinical trial is to evaluate if lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and cut down the time to recovery in hospitalized patients having severe or critical COVID-19 pneumonia.
Humanigen said that the data safety monitoring board (DSMB) held an interim analysis of the unblinded data for the sizing and powering of the clinical trial and recommended expanding the target number of events (recoveries) from 257 to 402 to sustain the power of the study at 90%.
The adaptive trial design only lets the addition of patients if interim data are in the promising zone, that is reaching or crossing an average improvement in recoveries of 29% through day 28.
As per DSMB’s recommendation, Humanigen intends to expand enrollment to achieve 402 events (nearly 515 patients). This increase in enrollment will make sure that an even higher probability of success in achieving the primary endpoint and the power of the study at 90% is maintained, said the company.
The next interim analysis for efficacy is expected to be released when the late-stage trial reaches 75% events (302 events) which will need around 390 patients to be enrolled.
Dale Chappell – chief scientific officer of Humanigen said: “Based on this feedback from the DSMB, we believe the Phase 3 trial is significantly de-risked. Targeting 402 events improves the probability of success, maintains the power of the study at 90 percent, and further supports our plans for Emergency Use Authorization (EUA) and Biologics License Application (BLA) submission.
“We are working to quickly activate additional trial sites across the U.S. to support rapid enrollment and increase access to lenzilumab with a continued commitment to inclusion and diversity.”
Humanigen plans to file for EUA in Q1 2021 either after interim data at 75% or at the completion of the study.