Evommune Initiates Phase 2 Trial of IL-18 Targeted Fusion Protein, EVO301, in Adult Patients with Atopic Dermatitis

• Unique approach targets IL-18 with a smaller, IL-18 fusion protein antagonist, with potential for more effective distribution to inflamed tissues than traditional monoclonal antibodies
• EVO301 has potential to be a first and best-in-class treatment option in atopic dermatitis (AD) and other IL-18 driven diseases

PALO ALTO, Calif., March 17, 2025 /PRNewswire/ -- Evommune, Inc., a clinical stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced the enrollment of the first patient in a Phase 2 trial of EVO301 in adult patients with moderate-to-severe AD. EVO301 is a serum albumin Fab-associated IL-18BP fusion protein designed to neutralize upregulated IL-18 activity, which is implicated in a range of inflammatory and autoimmune diseases.

"AD is a highly heterogenous disease, and for this reason, there remains a need for more effective treatments. While currently available therapies may improve some signs and symptoms, many AD patients do not respond optimally, and we believe EVO301 could, if approved, fulfill their search for a new and better treatment option. Based on our robust preclinical and Phase 1 clinical data, we are eager to confirm that the extended half-life expected with this IL-18BP fusion protein, has the potential to better serve patients with moderate-to-severe AD," said J. Mark Jackson, MD, Vice President, Clinical Development at Evommune.

The multi-center, randomized, double-blind, placebo-controlled, proof-of-concept trial is designed to evaluate the safety and efficacy of EVO301 in approximately 60 adult patients with moderate-to-severe AD. The primary objective of this study is to characterize the efficacy of EVO301, assessed by the percentage change in EASI from baseline at week 12. EASI, the Eczema Area and Severity Index score, is a tool used to measure the extent and severity of atopic dermatitis.

"Initiation of this trial marks another important milestone in Evommune's mission to deliver novel therapeutics to patients suffering from a broad range of chronic inflammatory diseases," said Luis Peña, President and Chief Executive Officer at Evommune. "EVO301 is our second clinical-development program, and this is the first of several trials in our development pipeline that will initiate in 2025. We are diligently executing to deliver multiple clinical milestones across our pipeline over the next 18 months."

About EVO301

A long-acting injectable therapeutic, EVO301 is a fusion-protein that is designed to neutralize the signaling pathway of IL-18 for the regulation of inflammation. IL-18, a proinflammatory cytokine of the IL-1 family, is upregulated in multiple inflammatory diseases and is a potent amplifier of inflammation. Traditionally, IL-18 is known to play an important role in the T-cell-helper type 1 inflammatory response, however, it may also play a role in other orthogonal inflammatory pathways, highlighting the potential utility of EVO301 in multiple inflammatory indications. Using native human IL-18 binding protein may reduce immunogenic potential compared to traditional monoclonal antibodies, and this serum albumin-binding fusion protein may allow for more effective distribution to inflamed tissues.

About Atopic Dermatitis:

Atopic Dermatitis is a chronic inflammatory skin disorder that affects approximately 40 million adults and 18 million children in the United States, Europe, Japan, and the United Kingdom, 40 percent of which have moderate-to-severe disease. Atopic dermatitis, which expresses elevated levels of IL-18, is characterized by abnormalities in immune regulation and skin barrier function. The disease typically manifests with itchy eczematous skin lesions. The disease has a significant impact on the patients' quality of life including sleep, self-esteem, interpersonal relationships, and participation in school or work.

About Evommune, Inc. 

Evommune, Inc. is a clinical-stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases. The company is creating game-changing science with the goal of delivering therapies that address symptoms and halt progressive disease. For more information, please visit www.evommune.com or follow us on LinkedIn.

SOURCE Evommune, Inc