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Humanigen believes that its anti-GM-CSF MAb lenzilumab could soon join these hallowed ranks, after reporting what it claimed were positive phase 3 results with the project today.
However, this success was based on a modified intent-to-treat analysis that excluded 33 patients – 19 in the active arm and 14 in the placebo cohort. As the study appears only to have narrowly met its primary endpoint in the mITT population, inclusion of these patients could have tipped the trial into failure.
Company execs said during a conference call today that the mITT analysis was the primary endpoint of the study, and added that mITT analyses were the standard across trials of Covid-19 agents, given the large number of patients who are typically randomised but do not end up receiving drugs.
However, a look at the Recovery trial, which was cited several times by the Humanigen execs, appears to contradict this view: cohorts of that study testing both dexamethasone and Roche’s Actemra both used intent-to-treat analyses.
The company was asked during today’s call to provide an analysis for the ITT population, but would not do so.