- Independent data safety monitoring board (DSMB) unanimously recommends trial continuation without modification after conducting pre-specified interim analysis for safety, futility, sample size and power
- Enrollment target of 300 patients expected to be completed this month
Humanigen, Inc., (HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm' with its lead drug candidate lenzilumab, today announced its Phase 3 registration trial of lenzilumab in patients with COVID-19 was unanimously recommended for continuation without modification by an independent DSMB after a planned interim analysis.
The DSMB, composed of independent subject matter experts, conducted a pre-specified interim analysis after 50% of the expected recoveries were captured in the trial database. The DSMB assessed the Phase 3 trial data for safety, futility, sample size and power assumptions. After completing their analysis, the DSMB unanimously recommended that the trial continue according to the existing trial protocol without modification.
"This unanimous recommendation by the independent DSMB is encouraging and marks another major milestone for Humanigen as we progress towards a potential EUA for lenzilumab in COVID-19," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. "We consider the decision to continue according to the existing protocol as a signal that the trial is progressing to plan."
Humanigen expects to complete the targeted enrollment of 300 patients this month with topline data available in the fourth quarter.
More details on Humanigen's programs in COVID-19 can be found on the company's website at www.humanigen.com under the COVID-19 tab, and details of the Phase 3 potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.