Insmed Phase 3 ARISE study meets primary endpoint; ARIKAYCE shows strong culture conversion in MAC lung disease

INSMED Inc

ARISE validated QOL-B respiratory domain as PRO tool; to be proposed as primary endpoint for ENCORE without modification.
ARIKAYCE arm achieved 78.8% culture conversion at Month 7 vs 47.1% for comparator (p=0.0010).
QOL-B respiratory score improvement trend: 12.24 vs 7.76 (p=0.1073); 43.8% of ARIKAYCE patients exceeded meaningful threshold.
No new safety signals; discontinuation rate 22.9% for ARIKAYCE vs 7.8% for comparator.
Insmed plans to explore accelerated filing for ARIKAYCE in newly infected MAC patients with global regulators.

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