Chennai: Humanigen, Inc., a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead investigational treatment lenzilumab, has 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).
“These interim data demonstrate the potential of lenzilumab as a frontline treatment option for patients hospitalized with Covid-19,” said Cameron Durrant, chief executive officer of Humanigen.
“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 data safety monitoring board (DSMB) composed of independent subject matter experts conducted 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 company 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. 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.
At the recommendation of the DSMB, the company plans to increase enrollment to achieve 402 events (approximately 515 patients). This increase in enrollment ensures an even higher probability of success in meeting the primary endpoint and maintains the power of the study at 90 percent.
The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial.
“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,” said Dale Chappell, chief scientific officer of Humanigen.
A Cooperative Research and Development Agreement (CRADA) that Humanigen entered into with the Joint Program Executive Office for Chemical, Biological Radiological and Nuclear Defense (JPEO-CBRND), provides for, among other support, regulatory, statistical and manufacturing subject matter advice to anticipation of an application for an EUA and eventually a BLA submission.
Humanigen intends to file for EUA in the first quarter of 2021 either following interim data at 75 per cent or at study completion.