Intellia Therapeutics said its lead hereditary angioedema drug, lonvoguran ziclumeran, delivered stronger Phase 3 results in the HAELO trial, adding to the 87% reduction in mean monthly attacks previously reported.
In the new data, the monthly rate of attacks requiring on-demand treatment fell to 0.19 in the lonvo-z arm from 1.79 in the placebo arm, an 89% reduction. The monthly rate of moderate or severe attacks dropped to 0.11 from 1.23, a 91% reduction.
The company also said quality-of-life scores improved more sharply with lonvo-z. The AE-QoL total score changed by -23.51 from baseline to week 28 in the treatment arm, compared with -6.47 in the placebo arm, a between-group difference of -17.04.
Previously disclosed results showed 62% of patients receiving lonvo-z were attack free and therapy free for the six-month efficacy evaluation period, versus 11% in the placebo group.
Intellia said the safety profile remained favorable. 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. All were mild or moderate, and the company said there were no serious adverse events in the lonvo-z arm.
The trial enrolled 52 patients in the lonvo-z arm and 28 in the placebo arm. Intellia said all patients in the lonvo-z group experienced attack-rate reductions from baseline during weeks 5 to 28, and meaningful reductions were seen across all evaluated subgroups.
The company said a rolling biologics license application submission began in April, and it continues to expect U.S. approval and launch in the first half of 2027. Following these announcements, the company's shares moved 10.82%, and are now trading at a price of $13.42. If you want to know more, read the company's complete 8-K report here.
