Humanigen Inc (HGENQ)

[DonDonDonDon]

HGEN's trial was for severe/critical patients, Activ5 is for moderate to critical.

Both lenzilumab Covid trials were for severe patients. No moderates or criticals in either trial.

Their p value was p=0.0365 but they had changed endpoints

The primary endpoint was changed but it was changed back to the original primary endpoint. So the trial started with vent-free survival as primary endpoint and the trial ended the trial with vent-free survival as the primary endpoint. It was an adaptive trial so changing the primary endpoint was allowed if the DSMB felt the trial was in "the promising zone".

The trial as a whole had a p value of .0365 (or .041). But the 256 patient subgroup on remdesivir with a CRP<150mg/L and under 85yo had a p value of 0.0002. In this patient population, 10.1% of lenz patients failed to go to vent free survival whereas 25.7% of placebo patients failed to go to vent-free survival for a hazard ratio of 3.22 (222% efficacy). That is now the exact patient population in the ACTIV-5 trial.