Intellia Therapeutics Presents Additional Positive Clinical and Patient-Reported Data for Lonvoguran Ziclumeran (lonvo-z) at ACAAI 2026
Key Highlights
- ➤HAELO LTP patients’ monthly attack rate decreased 81% after lonvo-z dosing
- ➤100% of 50 mg recipients remained LTP-free at data cutoffs
- ➤93 Phase 1/2 and HAELO patients saw 89% attack-rate reduction through four years
- ➤Lonvo-z improved AE-QoL by 23.5 points versus 6.5 for placebo at week 28
- ➤FDA accepted lonvo-z’s BLA with Priority Review and March 10, 2027 PDUFA date
Expert Statements
Danny Cohn, M.D., Ph.D., Associate Professor, Amsterdam University Medical Center; Phase 1/2 and HAELO principal investigator
“In the Phase 1/2 study, deep, consistent and durable reductions in plasma kallikrein were observed in all patients, with a mean reduction of 84% at four weeks that was maintained through up to four years of follow-up.”
Emel Aygören-Pürsün, M.D., Department for Children and Adolescents, Angioedema Centre, University Hospital Frankfurt, Goethe University; Phase 1/2 and HAELO principal investigator
“In the Phase 1/2 study (n=32), following a one-time 50 mg dose of lonvo-z, the proportion of patients who were attack-free after one year was at least 90% during each month with up to 4 years of follow-up.”
Marc Riedl, M.D., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association Angioedema Center, University of California San Diego; HAELO principal investigator
“Among the 35 HAELO patients taking LTP at study entry who were randomized to the lonvo-z arm, the mean HAE attack rate decreased by 81% during the efficacy observation period when compared to the attack rate while on prior LTP.”
Padmalal Gurugama, MBBS, M.S., M.D., MRCP, FRCPath, Consultant, Clinical Immunology and Allergy, Cambridge University Hospitals NHS Foundation Trust; Phase 1/2 and HAELO principal investigator
“In interviews with 23 Phase 1/2 patients with a median of 2.4 years of follow-up since lonvo-z infusion, all reported their HAE was well controlled following lonvo-z, compared with 48% before lonvo-z.”
Raffi Tachdjian, M.D., M.P.H., Associate Clinical Professor of Medicine and Pediatrics, Division of Allergy and Clinical Immunology, David Geffen School of Medicine, University of Los Angeles; HAELO principal investigator
“In a U.S. claims analysis of 538 HAE patients taking LTP over a median of 1.2 years, almost 40% were found to be non-adherent.”
William Lumry, M.D., Clinical Professor of Internal Medicine, Allergy and Immunology Division, University of Texas Southwestern Medical School, Medical Director, AARA Research Center; HAELO principal investigator
“HAELO met its key secondary endpoint of change from baseline to week 28 in Angioedema Quality of Life (AE-QoL) total score.”
Aleena Banerji, M.D., Professor at Harvard Medical School, Director of Clinical Care, Center for Drug and Vaccine Allergy at Massachusetts General Hospital; HAELO principal investigator
“Of the 93 patients who received a single one-time 50 mg dose of lonvo-z across the Phase 1/2 and Phase 3 HAELO studies, the overall attack rate reduction from baseline was 89% through up to four years of follow-up, and 97% of patients never initiated LTP after treatment.”
* Among patients previously on long-term prophylaxis (LTP) in HAELO Phase 3 trial, monthly attack rate decreased by 81% following lonvo-z dosing compared with prior LTP * 100% of patients receiving 50 mg of lonvo-z across Phase 1/2 clinical trial and HAELO were LTP-free as of the data cutoffs * Among 23 Phase 1/2 patients interviewed, all described their hereditary angioedema (HAE) as well controlled after receiving lonvo-z and 22 (96%) reported lonvo-z as an optimal HAE therapy * Intellia hosting investor webcast today at 10:00 a.m. ET CAMBRIDGE, Mass., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today announced highlights from its seven presentations at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, Arizona. Intellia will host an investor webcast today at 10:00 a.m. ET to review certain data from the ACAAI presentations, share perspectives from key opinion leaders and discuss the company’s preparations for a planned commercial launch of lonvo-z in HAE.
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