Evommune Starts Phase 2b Trial of EVO756 for Chronic Spontaneous Urticaria

PALO ALTO, CA, USA, April 15, 2025 - Evommune, Inc., a biotechnology firm engaged in clinical-stage research, has commenced a significant milestone with the enrollment of the first participant in its global Phase 2b trial for EVO756. This innovative oral therapy targets the mas-related G-protein coupled receptor X2 (MRGPRX2) and is intended for adults suffering from moderate to severe chronic spontaneous urticaria (CSU).

According to Luis Peña, President and CEO of Evommune, EVO756 offers a promising dual mechanism that addresses MRGPRX2 activation on both mast cells and peripheral sensory neurons. This mechanism has shown potential in preclinical studies, aiming to provide a new therapeutic approach not only for CSU but also for other inflammatory conditions in need of effective treatments. Building on these promising results, Evommune has begun its Phase 2b trial for CSU and is planning another Phase 2b trial for atopic dermatitis later this year.

Eugene Bauer, M.D., Evommune's Chief Medical Officer, highlighted that the ongoing enrollment for their open-label Phase 2 chronic inducible urticaria trial is nearly complete. The pharmacokinetic, pharmacodynamic, and safety data collected thus far justify the initiation of the Phase 2b trial. Evommune looks forward to sharing the CSU trial results in 2026.

The Phase 2b study is a global, multi-center, randomized, double-blind, placebo-controlled, dose-ranging trial. It aims to evaluate the efficacy and safety of EVO756 in adults with moderate to severe CSU. The trial plans to enroll approximately 160 patients, who will be randomly assigned to receive one of three active dosage regimens or a placebo.

Chronic spontaneous urticaria (CSU) is characterized by hives persisting for six weeks or more, occurring frequently without an identifiable cause. It affects approximately one in five people at some point in their lives. This condition arises from the activation of mast cells in the skin, leading to the release of substances like histamines and leukotrienes, which cause persistent itchy hives and skin inflammation. Although H1 antihistamines are commonly used to treat CSU by targeting H1 receptors, many patients experience inadequate control with these treatments and face limited alternatives.

MRGPRX2, a G-Protein-Coupled Receptor, plays a crucial role in triggering mast cell degranulation and neurogenic inflammation, contributing to sensations such as itch and pain. EVO756, a small molecule antagonist of MRGPRX2, is under development as a first-in-class, best-in-class oral treatment for diseases mediated by mast cells, including CSU and atopic dermatitis. The potential of EVO756 extends to other areas of neuroinflammation, addressing a critical need in both CSU and AD markets, which currently lack effective oral therapies with improved safety and efficacy profiles.

Evommune, Inc., at the forefront of biotechnology innovation, is committed to transforming the treatment landscape for immune-mediated inflammatory diseases. Their goal is to deliver groundbreaking therapies that not only alleviate disease symptoms but also halt disease progression.