Intellia lonvo-z Phase 3 HAELO Trial Shows 87% HAE Attack Reduction
Intellia Therapeutics presented additional positive Phase 3 HAELO clinical trial results for lonvo-z (formerly NTLA-2002) for hereditary angioedema (HAE) at the EAACI Annual Congress 2026, with simultaneous publication in the New England Journal of Medicine. The trial met its primary endpoint with an 87% reduction in mean monthly HAE attacks and showed 62% of patients were attack-free. Key secondary endpoints also demonstrated significant reductions in attacks requiring on-demand treatment (89%) and moderate/severe attacks (91%), alongside improved quality of life. The company initiated a rolling BLA submission in April and anticipates regulatory approval and a U.S. launch in H1 2027.
Key Highlights
- Primary endpoint met: 87% reduction (p<0.0001) in mean monthly HAE attacks for lonvo-z vs. placebo.
- 62% of lonvo-z patients were entirely attack-free and therapy-free for six months, vs. 11% for placebo (p<0.0001).
- 89% reduction (p<0.0001) in monthly attacks requiring on-demand treatment (lonvo-z arm: 0.19 vs. placebo: 1.79).
- 91% reduction (p<0.0001) in monthly moderate/severe attacks (lonvo-z arm: 0.11 vs. placebo: 1.23).
- Mean AE-QoL total score improved by -17.04 (p<0.0001) for lonvo-z vs. placebo.
- Favorable safety profile observed; all reported TEAEs were mild or moderate with no serious adverse events.
- Rolling Biologics License Application (BLA) submission for lonvo-z initiated in April with the U.S. FDA.
- Anticipates regulatory approval and U.S. launch in the first half of 2027.
Price Impact
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