Humanigen Inc (OTCQB:HGEN) announced Monday its Phase 3 registration trial of lenzilumab in patients with COVID-19 was unanimously recommended for continuation without modification by an independent DSMB (data safety monitoring board) after a planned interim analysis.
The DSMB, composed of independent subject matter experts, conducted a prespecified interim analysis after 50% of the expected recoveries were captured in the trial database, the company said in a statement.
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.
READ: Humanigen says lenzilumab demonstrated 80% reduction in relative risk of invasive mechanical ventilation and/or death in coronavirus patients
"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 CEO Dr Cameron Durrant.
"We consider the decision to continue according to the existing protocol as a signal that the trial is progressing to plan."
Humanigen said it expects to complete the targeted enrollment of 300 patients this month with topline data available in the fourth quarter.
Contact the author: firstname.lastname@example.org
Follow him on Twitter @PatrickMGraham