Evommune Announces Top Line Data from Phase 2 Trial of EVO756 in Chronic Inducible Urticaria Demonstrating Robust Activity and Favorable Safety Profile
-30 percent of patients achieved a complete response after 4 weeks of dosing, 50 percent of which were IgE high (≥100 IU/ml)
-41 percent of patients demonstrated a clinically meaningful response with ≥2 point reduction in itch numerical rating scale
-Data support ongoing development of EVO756 in Phase 2b trials in Chronic Spontaneous Urticaria and Atopic Dermatitis
-Full data set expected to be presented at upcoming medical meeting in second half of 2025
PALO ALTO, Calif., May 28, 2025 /PRNewswire/ -- Evommune, Inc., a clinical-stage biotechnology company developing innovative therapies for chronic inflammatory diseases, today announced positive top-line data from its Phase 2 trial of EVO756 in adults with chronic inducible urticaria (CIndU). EVO756 is a potent, highly selective oral small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). By targeting MRGPRX2, EVO756 has first in-class potential with a differentiated approach to treating disease, as it delivers modulation on both mast cells and peripheral sensory neurons.
"We are very pleased to report data that demonstrate excellent responses after only four weeks of treatment, supporting EVO756's potential to become a much-needed new treatment option for urticaria patients," said Luis Peña, President and Chief Executive Officer at Evommune. "These results are a testament to Evommune's team pursuit of scientific excellence. This also demonstrates our pipeline's potential to redefine treatment paradigms for those suffering from chronic inflammatory diseases," added Mr. Peña.
"As one who treats urticaria, these results suggest that EVO756, if approved, could present a compelling alternative to biologics, especially when we expect continued improvement and more responses with treatment beyond four weeks," commented Edward (Ted) Lain, MD, MBA., a board-certified dermatologist and clinical investigator. "There is a tremendous need for a medicine that could offer patients an effective treatment option along with the convenience of oral dosing, rapid itch reduction and a favorable safety profile," added Dr. Lain.
The multi-center trial evaluated the safety and efficacy of EVO756 in 30 patients with symptomatic dermographism, the most common form of CIndU. Enrollment targeted a real-world cross-section of patients with both IgE high (≥100 IU/ml) and low at baseline. Efficacy endpoints included changes from baseline in provocation test scores and pruritus. EVO756 was administered orally for four weeks at either 300mg once daily (QD) or 50mg twice daily (BID) and was evaluated for safety and efficacy at weekly visits during treatment, with patients serving as their own control. In the trial, clinically meaningful responses to treatment with EVO756 were consistent in both the 300mg QD and 50mg BID treatment groups, and EVO756 was generally well-tolerated with no serious treatment-emergent adverse events (TEAEs) and no discontinuations due to adverse events.
About Chronic Urticaria
Chronic urticaria, defined as urticaria persisting for more than six weeks, is a substantial burden for patients, their daily lives and families. Chronic urticaria manifests with very itchy hives (wheals) that may vary in size and can result in sleep deprivation, anxiety, depression, lack of energy, and social isolation which can result in a significant deterioration in the quality of life. Some patients with chronic urticaria may also develop swelling deeper under the skin or in other tissues (angioedema). There are two primary forms of chronic urticaria; in chronic spontaneous urticaria (CSU), hives occur spontaneously, without known triggers, and in CIndU, hives are induced by specific triggers such as touch (symptomatic dermographism) or cold exposure (cold urticaria), among others.
About Mas-related G protein-coupled receptor X2
MRGPRX2 is a G-Protein-Coupled-Receptor (GPCR) found predominantly on mast cells and peripheral sensory neurons. Mast cells are critical regulators of immune response and can be found in most vascularized tissues including skin, lung and the digestive tract. The receptor is activated by a broad spectrum of ligands that are prevalent during inflammation. Targeting MRGPRX2 may have potential across an array of chronic inflammatory diseases and play a role in mitigating neurogenic inflammation.
About EVO756
EVO756 is a small molecule antagonist of MRGPRX2 that is being developed as a potential first-in-class, best-in-class oral treatment for chronic inflammatory diseases, including CSU and atopic dermatitis (AD), with additional possible applications in neuroinflammation. Both the CSU and AD markets are underserved by current treatment options, and alternative therapies offering improved efficacy, safety, and the convenience of oral dosing are needed to fill the unmet need in these patients. By targeting MRGPRX2, we believe EVO756 is the only dual mechanism clinical approach that modulates both mast cells and peripheral sensory neurons, representing a new potential therapeutic option to reduce inflammation and provide rapid relief of itch (pruritus).
About Evommune, Inc.
Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. For more information, please visit www.evommune.com or our LinkedIn page.
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