Ionis reports positive Phase 3 results for donidalorsen in HAE; 81% attack reduction vs placebo

IONIS PHARMACEUTICALS INC

Donidalorsen met primary endpoint: 81% lower monthly HAE attack rate with Q4W dosing vs placebo (p<0.001) over 24 weeks.
OASISplus OLE showed continued improvement: 93% (Q4W) and 92% (Q8W) attack rate reduction from baseline after one year.
Switch cohort: patients switching from prior prophylactic to donidalorsen had 62% further reduction in mean monthly attack rates; 84% preferred donidalorsen.
Donidalorsen was well-tolerated; no related serious TEAEs. Injection site reactions most common AE.
Ionis plans to file NDA with FDA this year; Otsuka preparing MAA in Europe for donidalorsen.

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