CAMBRIDGE, Mass. - Intellia Therapeutics Inc. (NASDAQ:NTLA) presented additional Phase 3 clinical trial results for lonvo-z, its CRISPR gene editing treatment for hereditary angioedema, at the European Academy of Allergy & Clinical Immunology Annual Congress today, according to a press release statement.
The HAELO trial data, simultaneously published in the New England Journal of Medicine, showed lonvo-z reduced the monthly rate of attacks requiring on-demand treatment by 89% compared to placebo during weeks 5 to 28. The treatment arm recorded a mean monthly rate of 0.19 attacks versus 1.79 in the placebo arm.
The trial enrolled 52 patients in the lonvo-z arm and 28 in the placebo arm. Moderate to severe attacks were reduced by 91% in the lonvo-z group, with a mean monthly rate of 0.11 attacks compared to 1.23 in the placebo arm. Quality of life scores improved by 17.04 points more in the treatment group than placebo.Despite the positive clinical data, Intellia’s stock fell 11% over the past week to $12.11, though shares remain up 34% year-to-date. The company maintains a market capitalization of $1.69 billion.
The most common adverse events in the lonvo-z group were infusion-related reactions, headache, fatigue, back pain, and upper respiratory tract infection. All reported adverse events were mild or moderate, with no serious adverse events observed in the lonvo-z arm.
Hereditary angioedema affects approximately one in 50,000 people and causes severe, recurring inflammatory attacks. Current treatments often require chronic administration as frequently as twice weekly or daily.
Intellia initiated a rolling biologics license application with the U.S. Food and Drug Administration in April. The company anticipates regulatory approval and a U.S. launch in the first half of 2027.
Lonvo-z has received Orphan Drug and RMAT designations from the FDA, an Innovation Passport from the U.K. MHRA, and PRIME designation from the European Medicines Agency.
In other recent news, Intellia Therapeutics Inc. announced that data from its Phase 3 HAELO clinical trial will be presented at the European Academy of Allergy & Clinical Immunology Annual Congress. This trial evaluates lonvoguran ziclumeran, a CRISPR-based gene editing therapy, in patients with hereditary angioedema. Meanwhile, Intellia priced a $180 million follow-on equity offering at $10.75 per share, representing an 18.6% discount to its recent closing price. This offering, initially announced at $150 million, was upsized to $180 million, contributing to a dilution effect. Following this, H.C. Wainwright reduced its price target for Intellia to $25 from $30, while maintaining a Buy rating due to the dilution from the recent financing. Additionally, Baird reported that Intellia recorded the highest increase in short interest among biotech stocks, rising to 39% from 35%. These developments highlight significant financial and clinical activity for the company.
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