The Independent Data Safety Monitoring Board (DSMB) has completed pre-specified interim analysis for Humanigen’s (OTCQB:HGEN) lead drug candidate lenzilumab Phase 3 trial for COVID-19 and recommended that the study continue unmodified.
The DSMB conducted the analysis after 50% of the expected recoveries were captured, and assessed the Phase 3 trial data for safety, futility, sample size and power assumptions.
The company expects to complete the targeted enrollment of 300 patients this month, with topline data expected in the next quarter.
Lenzilumab is a Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
Recently, the company announced lenzilumab demonstrated positive effect in COVID-19 in case-control study
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