EVO-756

Clinical responses observed in 93 percent of patients at just four weeks in either FricTest Score or Pruritus-NRS, with improvements seen as early as week one Favorable safety and tolerability profile observed; consistent with previously disclosed Phase 1 healthy volunteer study CIndU results support the potential of translatable clinical activity in Chronic Spontaneous Urticaria (CSU) and Atopic Dermatitis (AD) On-demand webinar with full data now available on Evommune website PALO ALTO, Calif., Sept. 19, 2025 /PRNewswire/ -- Evommune, Inc., a clinical-stage biotechnology company discovering and developing innovative therapies that target key drivers of chronic inflammatory diseases, today presented additional positive data from its Phase 2 trial of EVO756 in adults with chronic inducible urticaria (CIndU) in a late-breaker oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France. Evommune previously announced top-line data from this trial in May 2025. "The full Phase 2 data presented today highlight EVO756's differentiated mast cell dual mechanism, with responses observed as early as one week and after four weeks of oral treatment. Additionally, EVO756 was generally well-tolerated, and when taken together with the previously announced top-line data, these data also demonstrate the potential for more improvement with continued dosing beyond four weeks, suggesting that EVO756, if approved, could be a compelling alternative to biologics and other approaches," commented Edward (Ted) Lain, M.D., M.B.A., a board-certified dermatologist and clinical investigator. EVO756 is a potent and highly selective oral small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). By targeting MRGPRX2, Evommune believes EVO756 has industry-leading potential with a differentiated approach to treating disease. EVO756 has been observed to deliver modulation on both mast cells and peripheral sensory neurons, representing a new potential therapeutic option to reduce inflammation and provide rapid relief of itch (pruritus). This multicenter, Phase 2 trial was conducted in 30 adults with symptomatic dermographism (common CIndU subtype) with patients serving as their own control. Patients needed to qualify at both screening and baseline, without demonstrating spontaneous resolution during the 30-day screening window. Enrollment targeted a real-world cross-section of patients with both IgE high (≥100 IU/ml) and low at baseline. EVO756 was administered orally for four weeks at either 300mg once daily (QD) or 50mg twice daily (BID). Efficacy was measured by FricTest provocation scores and Pruritus Numeric Rating Scale (NRS) and safety assessments were performed at each visit. Key data highlights include: Robust clinical activity in both 300 mg QD and 50mg BID doses: Clinical responses observed in 93 percent of patients at just four weeks in either FricTest score or Pruritus-NRS; 70 percent of patients demonstrated an improvement in FricTest score at just four weeks, with 30 percent of patients achieving a complete response; reduced Pruritus-NRS observed at week 4 in 78 percent of patients, with a ≥4-point reduction observed in 41 percent Rapid onset: Improvements in both Pruritus NRS and FricTest scores observed within one week (including three patients with complete responses) Broad applicability: 50 percent of complete responders were IgE high (≥100 IU/mL), demonstrating clinical improvement was not limited to IgE low subjects Well-tolerated: No serious adverse events or treatment discontinuations due to adverse events "These encouraging data demonstrate that by targeting MRGPRX2, EVO756 modulates both mast cells and peripheral sensory neurons, representing a new potential therapeutic approach that can impact the underlying disease by both reducing inflammation and providing rapid relief of itch. Today's presentation marks the first detailed clinical data publicly presented on this dual mechanism," said J. Mark Jackson, M.D., Vice President, Clinical Development at Evommune. "Despite different triggers, aberrant mast cell activation is common to CIndU, CSU and AD and early relief of the hallmark symptom of itch in CIndU has the potential to translate similarly in CSU and AD. We look forward to sharing top-line data from our ongoing Phase 2b studies of EVO756, with CSU data expected in the first half of 2026 and AD data expected in the second half of 2026." A link to the on-demand webinar featuring a discussion of these results is now available in the Headline banner on the Evommune website at . 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 Evommune is developing EVO756 with the intent of producing the first MRGPRX2-targeted 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, Evommune believes 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. is a clinical-stage biotechnology company discovering and developing innovative therapies that target key drivers of chronic inflammatory diseases. The company's mission is to improve patients' daily lives and prevent the long-term effects of uncontrolled inflammation that are a consequence of the limitations of existing therapies. To achieve this, Evommune is advancing a portfolio of differentiated product candidates that target key drivers of chronic inflammation. For more information, please visit or follow us on LinkedIn. SOURCE Evommune, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MRGPRX2 antogonism is the only known mechanism of action designed to modulate mast cells and sensory neurons, both key drivers in the neuroimmune interaction that drives lesions and intense itch in atopic dermatitis (AD) EVO756 is specifically designed to address the need for a safe and effective oral therapy with disease modulation and fast onset of itch relief of patients with uncontrolled disease AD trial is Company's second Phase 2b program evaluating EVO756; highlighting EVO756's broad potential for patients suffering from a range of chronic inflammatory diseases Top-line data from the Phase 2b AD trial expected in second half of 2026 PALO ALTO, Calif., Aug. 27, 2025 /PRNewswire/ -- Evommune, Inc., a clinical stage biotechnology company discovering and developing innovative therapies that target key drivers of chronic inflammatory diseases, today announced the enrollment of the first patient in a Phase 2b trial of EVO756, a highly potent and selective orally administered small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2), to assess the efficacy and safety in adults with moderate to severe atopic dermatitis (AD). "MRGPRX2 is one of the most important new targets in chronic inflammation, and we believe our industry leading development candidate, EVO756, has the potential to be a critically needed oral therapeutic for AD, as well as a broad range of other inflammatory diseases. We expect to have several potential clinical inflection points in 2026, as we now have two Phase 2 programs underway with EVO756 and EVO301 in AD, and continue to rapidly enroll patients in our chronic spontaneous urticaria Phase 2b trial of EVO756," said Luis Peña, Chief Executive Officer at Evommune. Translational data generated by Evommune and others have demonstrated the increased presence of mast cells and MRGPRX2 ligands in AD diseased-tissue and lesions. In a Phase 2 trial with chronic inducible urticaria (symptomatic dermographism) patients, Evommune observed the role of MRGPRX2 antagonism in modulating neurogenic inflammation and mast cell activation. Evommune believes these data further support the rationale for the initiation of this trial in AD, a disease where itch and pain phenotypes, driven by neurogenic inflammation and mast cell degranulation, and exacerbated by the itch-scratch cycle, play a key role in disease pathophysiology. "There is still a significant need for better treatment options for AD patients, particularly for the intense itch which is the primary symptom driving patients to physicians. MRGPRX2 antagonism is exciting in its potential to change the paradigm as the first target that modulates both mast cells and sensory neurons," said Eugene Bauer, M.D., Chief Medical Officer at Evommune. The Phase 2b trial of approximately 120 patients is a randomized, multi-center, double-blind, placebo-controlled, dose-ranging trial which will assess the efficacy and safety of EVO756 in adult patients with moderate to severe AD. Patients will be randomized to receive EVO756 or matching placebo for 12 weeks. The primary objective of this trial is to characterize the efficacy of multiple dose levels of EVO756 compared to placebo as assessed by the percentage change in Eczema Area and Severity Index (EASI) from Baseline to Week 12. A key secondary endpoint is the evaluation of Pruritus-NRS, a tool used to assess the severity of itching. About Atopic Dermatitis AD, commonly referred to as eczema, is one of the most prevalent chronic inflammatory diseases and is characterized by acute flares of itchy, red, exudative papules and persistently dry, scaly skin. The hallmark feature of AD is intense inflammatory itch, known as pruritus, which triggers an inflammatory cascade with mast cells and drives underlying chronic inflammation. For most moderate-to-severe AD patients, the disease significantly impacts patients' quality of life, driven primarily by relentless itch, sleep disruption and visible skin symptoms. The intense itch associated with AD often triggers an itch-scratch cycle, further compromising the epidermal barrier and exacerbating disease. While AD commonly begins in childhood, it is also highly and increasingly prevalent in adults, with about 15 percent to 20 percent of children and one percent to three percent of adults impacted, significantly disrupting their quality of life. 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. By addressing dysregulated MRGPRX2 activity, a key driver of disease pathogenesis in numerous systemic chronic inflammatory diseases, EVO756 could offer a novel, multipronged mechanism to modulate inflammation. This transformative therapeutic approach is initially focused on ongoing Phase 2b trials in chronic spontaneous urticaria and moderate-to-severe AD, with the potential for broader applications across many other chronic inflammatory diseases such as asthma, migraine, inflammatory bowel syndrome, interstitial cystitis, and pruritus. About Evommune Evommune, Inc. is a clinical-stage biotechnology company discovering and developing innovative therapies that target key drivers of chronic inflammatory diseases. The company's mission is to improve patients' daily lives and prevent the long-term effects of uncontrolled inflammation that are a consequence of the limitations of existing therapies. To achieve this, we are advancing a portfolio of differentiated product candidates that target key drivers of chronic inflammation. For more information, please visit or follow us on LinkedIn. SOURCE Evommune, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED