Ionis Pharmaceuticals (Nasdaq: IONS) yesterday announced positive top-line results for the Phase III OASIS-HAE study of donidalorsen in people with hereditary angioedema (HAE), with the news sending the US RNA-targeted drug developer’s shares up more than 5% to $53.58.
The trial met its primary endpoint of reduction in rate of angioedema attacks in patients treated with donidalorsen (80mg) via subcutaneous injection dosed every four weeks (Q4W) (p<0.001) or every eight weeks (Q8W) (p=0.004), compared to placebo.
In addition, the trial showed donidalorsen achieved statistical significance on all secondary endpoints in the Q4W group and key secondary endpoints in the Q8W group. Donidalorsen demonstrated a favorable safety and tolerability profile in the study, and there were no serious adverse events in the patients treated with donidalorsen.
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