Humanigen announces positive interim Phase 3 data on lenzilumab to treat patients hospitalized with COVID-19

Humanigen Inc (NASDAQ:HGEN) (FRA:0KB2) announced Friday positive interim Phase 3 data on lenzilumab to treat patients hospitalized with COVID-19.  In a statement, the company said this interim analysis for sizing and powering, suggests that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37% 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 CEO Dr Cameron Durrant. “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.” READ: Humanigen inks licensing deal for coronavirus drug lenzilumab in South Korea and the Philippines Humanigen said 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%.  The adaptive trial design only allows for the addition of patients if interim data are in the “promising zone” (ie: achieving or surpassing an average improvement in recoveries of 29% (hazard ratio (HR) > 1.29 through day 28). The company said it 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% 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, Humanigen noted.  At the recommendation of the DSMB, Humanigen said it plans to increase enrollment to achieve 402 events (about 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%. The next interim analysis for efficacy is planned when the study reaches 75% events (302 events), which will require about 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%, and further supports our plans for Emergency Use Authorization (EUA) and Biologics License Application (BLA) submission,” said Dr Dale Chappell, chief scientific officer. “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.” 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 in anticipation of an application for an EUA and eventually a BLA submission.  Humanigen said the activities under the CRADA are being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS), working in collaboration with JPEO-CBRND. These activities include providing regulatory representatives who may participate in informal or formal meetings with the US Food and Drug Administration and providing comments on submission prior to submitting to FDA. Interim Phase 3 highlights Humanigen said it intends to file for EUA in the first quarter of 2021 either following interim data at 75% or at study completion. The Phase 3 trial evaluating patients hospitalized with COVID-19 is enrolling at sites across the US and Latin America. Current enrollment stands at 300 patients. Interim Phase 3 lenzilumab in COVID-19 data analysis highlights: 78% of trial participants on either remdesivir or dexamethasone (or other steroids) or both (across both arms of the study); 65% of trial participants with oxygen saturation 94% or on low-flow oxygen support; 35% of trial participants on high-flow oxygen or non-invasive positive pressure ventilation at time of enrollment; 45% of trial participants were 65 years of age or older; 50% of trial participants from diverse populations; and No serious adverse events have been attributed to lenzilumab Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham