Clinical TrialJun 15, 2026, 09:01 AM
Intellia Therapeutics Reports Positive Phase 3 Lonvo-z Data for HAE
AI Summary
Intellia Therapeutics announced additional positive Phase 3 results for its hereditary angioedema (HAE) treatment, lonvoguran ziclumeran (lonvo-z). The HAELO trial demonstrated a significant 87% reduction in mean monthly attacks and 62% of patients remaining attack-free for six months. Key secondary endpoints also showed substantial improvements, including an 89% reduction in attacks requiring on-demand treatment and a 91% reduction in moderate/severe attacks. The drug exhibited a favorable safety profile with no serious adverse events reported. Intellia has initiated a rolling BLA submission and anticipates a U.S. launch in the first half of 2027.
Key Highlights
- Intellia Therapeutics reports additional positive Phase 3 HAELO trial results for lonvoguran ziclumeran (lonvo-z) in hereditary angioedema (HAE).
- 87% reduction in mean monthly attacks (p<0.0001) in lonvo-z arm vs. placebo.
- 62% of patients on lonvo-z were attack-free and therapy-free for six months (p<0.0001).
- Monthly rate of attacks requiring on-demand treatment reduced by 89% (p<0.0001).
- Monthly rate of moderate/severe attacks reduced by 91% (p<0.0001).
- AE-QoL score improved by -17.04 points (p<0.0001), indicating improved quality of life.
- Favorable safety profile observed with mild to moderate TEAEs; no serious adverse events in lonvo-z arm.
- Rolling BLA submission initiated in April; anticipates regulatory approval and U.S. launch in H1 2027.
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