Intellia Therapeutics reported additional Phase 3 results for lonvoguran ziclumeran in hereditary angioedema, showing the treatment continued to cut attack rates sharply versus placebo across multiple endpoints in the HAELO trial.
The company said lonvo-z reduced the monthly rate of attacks requiring on-demand treatment to 0.19 from 1.79 in the placebo arm, an 89% reduction. Monthly moderate or severe attacks fell to 0.11 from 1.23, a 91% reduction.
Quality of life also improved more strongly with lonvo-z. The AE-QoL total score fell by 23.51 points from baseline to week 28, compared with a 6.47-point decline in the placebo group, a 17.04-point advantage.
Those results followed the previously announced primary endpoint, which showed an 87% reduction in mean monthly attacks during weeks 5 through 28. Intellia also said 62% of patients in the lonvo-z arm were entirely attack free and therapy free for the six-month efficacy period, compared with 11% in the placebo arm.
Safety data showed the most common treatment-emergent adverse events in the lonvo-z group were infusion-related reaction, headache, fatigue, back pain and upper respiratory tract infection. The company said all reported treatment-emergent adverse events were mild or moderate, and there were no serious adverse events in the lonvo-z arm.
Intellia said a rolling biologics license application submission was initiated in April and it continues to expect regulatory approval and a U.S. launch in the first half of 2027. Following these announcements, the company's shares moved 19.57%, and are now trading at a price of $14.48. Check out the company's full 8-K submission here.
