Evommune has reported top-line results from its Phase 2b clinical trial of its oral MRGPRX2 antagonist EVO756 in adults with moderate-to-severe chronic spontaneous urticaria (CSU), revealing the study failed to meet its primary efficacy endpoint.
The randomized, double-blind, placebo-controlled, dose-ranging trial enrolled 160 antihistamine-refractory CSU patients across the United States, Europe, Canada and Japan. Participants received one of three active dose regimens or placebo.
At 12 weeks, EVO756 did not achieve a statistically meaningful improvement in mean change in Urticaria Activity Score over seven days (UAS7) at any dose tested.
“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. We are sincerely grateful to the patients, clinicians and administrators who participated in this trial.”
Despite the setback in CSU, Evommune said it remains committed to the broader therapeutic potential of MRGPRX2 modulation in inflammatory disease.
"While we are disappointed with the trial results in this indication, we continue to believe that modulation of MRGPRX2 represents a new potential therapeutic option to reduce inflammation and provide rapid relief of symptoms.
"We remain on track to report top-line Phase 2b data for EVO756 in atopic dermatitis (AD) in the third quarter of 2026. We have also initiated screening in a Phase 2b trial of EVO756 in migraine prophylaxis, and expect patient dosing to commence imminently.
"For EVO301, our IL-18BP fusion protein, we recently reported positive Phase 2a proof-of-concept data in AD and look forward to moving the program into a robust Phase 2b AD trial,” said Luis Peña, President and Chief Executive Officer at Evommune.
“With a strong cash position supporting our anticipated operations through 2028, we believe we are well positioned to execute on key milestones and further advance our pipeline of therapies addressing chronic inflammatory diseases.”
