Evommune's EVO756 Misses Primary Endpoint in Phase 2b Chronic Spontaneous Urticaria Trial, Pivots to Atopic Dermatitis and Migraine
核心洞察
Evommune's oral MRGPRX2 (搜索) antagonist EVO756 failed to meet the primary endpoint of mean change in UAS7 at 12 weeks in a Phase 2b trial of 160 moderate-to-severe antihistamine-refractory CSU patients.
The company confirmed EVO756 was safe and well-tolerated at all doses tested and will discontinue CSU development while advancing the drug in atopic dermatitis (搜索) and migraine (搜索).
Top-line Phase 2b data for EVO756 in atopic dermatitis (搜索) is expected in Q3 2026, with a Phase 2b migraine (搜索) prophylaxis trial initiating patient dosing imminently.
Evommune, Inc. (NYSE: EVMN) announced on June 29, 2026 that its randomized, double-blind, placebo-controlled, dose-ranging Phase 2b trial of oral EVO756 in moderate-to-severe chronic spontaneous urticaria (搜索) (CSU) did not meet its primary endpoint. The trial, which enrolled 160 antihistamine-refractory CSU patients across the United States, Europe, Canada, and Japan, evaluated three active dose regimens against placebo and found no statistically significant improvement in mean change in Urticaria Activity Score over seven days (UAS7) at 12 weeks at any dose.
"EVO756 previously delivered positive Phase 2 data in chronic inducible urticaria and showed clear target engagement in the Phase 1 trial, however, the lack of efficacy demonstrated at Week 12 in this Phase 2b trial does not support further development of EVO756 for CSU," said Dr. Eugene Bauer, Chief Medical Officer of Evommune. "We are evaluating EVO756 in additional indications, and this Phase 2b trial confirmed safe and well tolerated doses that warrant these further studies."
Pipeline Reprioritization and Forward Strategy
Despite the setback in CSU, Evommune remains committed to the therapeutic potential of MRGPRX2 (搜索) antagonism. EVO756 is a first-in-class, potent and highly selective oral small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2), a receptor predominantly found on mast cells and peripheral sensory neurons. The company is advancing the molecule in two additional indications.
Luis Peña, President and Chief Executive Officer at Evommune, outlined the path forward: "We remain on track to report top-line Phase 2b data for EVO756 in atopic dermatitis (搜索) (AD) in the third quarter of 2026. We have also initiated screening in a Phase 2b trial of EVO756 in migraine (搜索) prophylaxis, and expect patient dosing to commence imminently."
The migraine (搜索) expansion is supported by emerging scientific rationale. In a KOL webinar hosted by Evommune on April 13, 2026, Greg Dussor, Ph.D., Professor and Department Head of Neuroscience at the University of Texas – Dallas, discussed the role of MRGPRX2 (搜索) in migraine pathophysiology. Stewart Tepper, M.D., Professor of Neurology at Geisel School of Medicine at Dartmouth, highlighted the significant unmet need in the migraine treatment landscape during the same event.
Broader Pipeline Developments
Beyond EVO756, Evommune reported progress with EVO301, its IL-18BP fusion protein, which recently delivered positive Phase 2a proof-of-concept data in atopic dermatitis (搜索). The company plans to advance EVO301 into a robust Phase 2b AD trial.
Evommune stated it holds a strong cash position supporting anticipated operations through 2028, positioning the company to execute on key milestones across its pipeline of therapies targeting chronic inflammatory diseases.