Evommune Begins Phase 2 Trial of EVO756 for Chronic Inducible Urticaria

PALO ALTO, CA, USA I September 3, 2024 I Evommune, Inc., a clinical-stage biotechnology firm focusing on new treatments for immune-mediated inflammatory diseases, has announced the enrollment of the first patient in a Phase 2 clinical trial of EVO756, aimed at adults with Chronic Inducible Urticaria (CIndU). EVO756 is a small molecule that acts as a highly selective antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). This new approach aims to provide a once-daily oral treatment without the severe side effects linked to existing therapies.

"As we move forward with our clinical development plans for EVO756, this Phase 2 trial will be conducted across 15 sites in the United States. Currently, CIndU patients have limited treatment options. We believe that a novel, potent, and selective agent, capable of being administered once daily, could offer significant therapeutic benefits," stated J. Mark Jackson, MD, Vice President of Clinical Development at Evommune.

The trial aims to assess the safety and efficacy of EVO756 in about 30 patients suffering from either symptomatic dermographism or cold urticaria, the two most prevalent forms of CIndU. The efficacy will be evaluated based on changes from baseline in disease-specific provocation thresholds, which serve as objective markers to measure disease severity and treatment response. Patients will receive once-daily oral doses of EVO756 for four weeks, with safety and efficacy assessments conducted at weekly intervals during treatment. Each patient will serve as their own control in the study.

"The initiation of this trial is another significant milestone in our commitment to harnessing the therapeutic potential of MRGPRX2 antagonism for patients with various mast cell-mediated disorders," said Daniel J. Burge, M.D., Senior Vice President of Clinical Development at Evommune. "Following the successful proof-of-concept study of EVO756 earlier this year, we are also planning to begin a Phase 2b trial in chronic spontaneous urticaria by the second quarter of 2025."

Chronic Urticaria Overview
Chronic urticaria, defined as urticaria lasting more than six weeks, poses a significant burden on patients, their families, the healthcare system, and society. Patients experience intensely itchy hives that can vary in size and lead to sleep deprivation, anxiety, depression, fatigue, and social isolation, all of which significantly deteriorate the quality of life. Some patients may also develop angioedema, causing deeper swelling under the skin or in other tissues. There are two primary forms of chronic urticaria: chronic spontaneous urticaria (CSU), where hives occur without known triggers, and chronic inducible urticaria (CIndU), where hives are triggered by specific factors like cold exposure (cold urticaria) or touch (symptomatic dermographism).

Chronic urticaria is driven by mast cells. Activated mast cells release histamine and other mediators, such as platelet-activating factors and cytokines. This results in sensory nerve activation, vasodilation, plasma extravasation, and cell recruitment to the urticarial lesion.

About EVO756
EVO756 is a potent and highly selective small molecule antagonist of MRGPRX2, a receptor predominantly found on mast cells and peripheral sensory neurons. MRGPRX2 can activate independently of IgE through multiple ligands, causing a variety of symptoms depending on the affected tissue. Evommune’s pre-clinical studies indicate that EVO756 can block MRGPRX2 activation across all relevant ligand categories, preventing mast cell degranulation. This small molecule has the potential to be a first-in-class oral treatment for various mast cell-mediated diseases. Additionally, due to its unique function on peripheral sensory neurons, EVO756 could provide rapid relief from itch associated with inflammatory conditions like atopic dermatitis.

About Evommune, Inc.
Evommune, Inc., a biotechnology company based in Palo Alto, is at the forefront of developing groundbreaking science to treat immune-mediated inflammatory diseases. The company is dedicated to discovering, developing, and delivering therapies that address symptoms and halt disease progression.

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