Shares of Evommune, Inc. fell roughly 17% on Monday after the company disclosed that its Phase 2b study of EVO756 in chronic spontaneous urticaria (CSU) did not achieve its primary endpoint.
The primary efficacy measure for the trial was the mean change in Urticaria Activity Score over seven days (UAS7) at 12 weeks. According to the company, the study failed to meet this endpoint at any of the dose levels tested.
The trial was a randomized, double-blind, placebo-controlled study that enrolled 160 patients with moderate-to-severe antihistamine-refractory CSU. Participants were recruited across the United States, Europe, Canada and Japan and were assigned to one of three active dose regimens or to placebo.
Following the readout, Evommune said it will not pursue further development of EVO756 for CSU. The company nonetheless plans to continue advancing the oral MRGPRX2 antagonist into additional indications, specifically atopic dermatitis and migraine.
Evommune's chief medical officer, Dr. Eugene Bauer, said the Phase 2b trial confirmed doses that were safe and well tolerated and that these findings support further study of EVO756 in other therapeutic areas.
The company provided a near-term development roadmap: top-line Phase 2b data for EVO756 in atopic dermatitis are expected in the third quarter of 2026, and the firm has initiated screening for a Phase 2b study of EVO756 in migraine prophylaxis, with patient dosing expected to begin soon.
Separately, Evommune reported positive Phase 2a proof-of-concept results for its IL-18 binding protein fusion candidate EVO301 in atopic dermatitis and intends to progress that program into a Phase 2b trial.
Evommune also stated that it holds a cash position sufficient to support its anticipated operations through 2028.
Context and implications
The failure to meet the primary endpoint in CSU has led the company to stop development of EVO756 for that indication while reallocating resources to other planned programs. The clinical readout establishes safety and tolerability at the tested doses, which the company says underpins continued investigation in atopic dermatitis and migraine.
Investors reacted to the CSU setback with a notable sell-off in the company stock, reflecting the market sensitivity of early- to mid-stage clinical results.