ADARx to Present Onvuzosiran Phase 1/2 Data at AAAAI and EAACI 2026 Meetings
ADARx will present onvuzosiran Phase 1/2 data and Phase 3 STOP-HAE design at AAAAI and EAACI 2026. The investigational siRNA for hereditary angioedema has FDA Orphan Drug Designation.
ADARx Pharmaceuticals, Inc. will present Phase 1/2 clinical data for onvuzosiran (ADX-324), its investigational small interfering RNA (siRNA) therapeutic candidate for hereditary angioedema (HAE), at the 2026 annual meetings of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the European Academy of Allergy and Clinical Immunology (EAACI). The presentations will include the design of the ongoing Phase 3 STOP-HAE clinical trial.
The AAAAI Annual Meeting takes place February 27 – March 2, 2026, in Philadelphia, PA. The EAACI Annual Meeting takes place June 12-15, 2026, in Istanbul, Turkey. At EAACI, the poster presentation, titled “Onvuzosiran Provides Deep and Sustained Reduction of Plasma Kallikrein Levels for the Treatment of HAE” (Abstract number: 100399), is scheduled for Saturday June 13, from 8:45 – 9:45 am TRT in Room Glasgow at the Istanbul Congress Center, as part of the Flash Talks session (L-FT04) entitled Immune deficiencies and autoimmunity.
HAE is a rare genetic disorder characterized by recurrent, unpredictable attacks of swelling that can be painful, disabling, and life-threatening. These attacks result from dysregulation of the kallikrein-kinin system (KKS), which regulates blood pressure, inflammation, coagulation and pain. Prekallikrein (PKK) is a critical protein in the plasma kallikrein pathway that activates a second protein called kallikrein, which, if present, produces bradykinin, a potent vasodilator. A dysfunctional KKS leads to excessive release of bradykinin which causes the swelling attacks in HAE.
Onvuzosiran is an investigational siRNA therapy designed to inhibit PKK generation at the mRNA level and reduce the production of plasma PKK, thereby averting bradykinin generation and potentially preventing HAE attacks. Compared to currently approved prophylactic treatments, onvuzosiran is expected to decrease PKK to a greater degree, offering the potential for greater and more durable control of kallikrein activity, which is expected to result in a higher proportion of patients remaining attack-free with a less frequent dosing regimen. Onvuzosiran is currently being evaluated in the Phase 3 STOP-HAE clinical trial and has received Orphan Drug Designation for the treatment of patients with HAE from the U.S. Food and Drug Administration (FDA).
ADARx Pharmaceuticals, Inc. is a late-stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. The company is focused on advancing and expanding a deep pipeline of highly potent, durable and selective RNA-targeted therapeutic candidates, developing product candidates for the treatment of complement-mediated, genetic, cardiovascular, thrombosis, central nervous system and metabolic (obesity) diseases. In addition to its wholly-owned programs, ADARx has entered into a collaboration and license option agreement with AbbVie to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology.