Evommune’s potential Dupixent competitor has met its primary endpoint in a Phase IIa atopic dermatitis (AD) trial, achieving a 33% reduction on the Eczema Area and Severity Index (EASI).
In the randomised, double blind, placebo-controlled study (NCT06723405), intravenous (IV) EVO301’s EASI reduction was statistically significant at weeks four, eight and 12. At week four, there was a 23% placebo adjusted reduction, at week eight, the reduction was 34%, and at week 12, it reduced slightly to 33%. This is partially due to a placebo EASI increase between weeks four and eight, before a drop again at week 12.
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This reduction is competitive to Sanofi’s flagship AD drug Dupixent (dupilumab), which achieved a 35% and 36% reduction in EASI after 16 weeks in Phase III trials.
The success criterion required at least 75% of the posterior distribution to be an improvement of at least 8% over placebo; the results of the study demonstrated 99.8% of the posterior distribution met that threshold.
Evommune’s stock rose 70.86% on the data, from a 9 February close of $16.99 to a 10 February close of $29.03. The company has a market cap of $915m.
On top of the primary endpoint success, key secondary endpoints also showed statistical significance, with 23% of patients treated with EVO301 achieving validated Investigator’s Global Assessment for Atopic Dermatitis scores of 0 or 1 (vIGA-AD 0/1) at week 12, compared to 0% in the placebo cohort.
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By GlobalDataPharmacokinetics were consistent with the Phase I healthy volunteer trial and continue to support four-weekly dosing. The drug also continued to be well tolerated, with no drug-related serious or severe adverse events (AEs) reported. There were no treatment-related discontinuations due to AE and no meaningful differences in events between the active and placebo groups.
The trial also showed robust reduction of both Th2 and non Th2 inflammatory biomarkers in AD, including CCL-17 (TARC), CCL-22 and IL-22.
Dr Mark Lebwohl, Dean for Clinical Therapeutics and Chairman Emeritus of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, said: “These data underscore that impacting pathways beyond only Th2 biology can meaningfully contribute to AD disease activity. EVO301’s ability to target the novel IL-18 mechanism and show clinically relevant treatment activity, without side effects, could offer real benefit for patients in such a heterogeneous disease.”
Full data from the Phase IIa study will be presented at an upcoming scientific conference. EVO301 is also being investigated in a Phase IIb dose-ranging trial, evaluating a subcutaneous version of the drug.
EVO301 is a long-acting fusion protein consisting of an interleukin-18 (IL-18) binding protein and an anti-serum albumin Fab-associated domain. Based on its mechanism of action (MoA), Evommune hopes the drug will also show promise in other inflammatory indications, such as ulcerative colitis (UC).
This is not the only candidate Evommune is investigating in AD, with EVO-756, an MRGPRX2 antagonist, being investigated in a Phase IIb trial (NCT07150845). Research shows that by inhibiting MRGPRX2, neuro-inflammatory responses can be reduced, which will block itchiness.
According to GlobalData, parent company of Clinical Trials Arena, sales in the AD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is estimated to grow from $8.5bn in 2023 to $22.4bn by 2033.
The AD market has grown significantly since Dupixent’s approval in 2017, a drug that now accounts for much of global drug sales in the disease. Sanofi has released data from its Dupixent successor amlitelimab, with the trial having met its primary endpoint. Sanofi is also speaking with regulators about the potential approval pathway for amlitelimab based on the Phase III trial data.
Filippos Maniatis, healthcare analyst at GlobalData, said: “AD is a growing market with an impressive pipeline of new products from current and future players in the field. The AD space was previously dominated by broad-acting immunomodulatory agents, which are now being slowly replaced by more targeted agents. This shift is likely due to better comprehension of the pathophysiology behind AD and the approval of several new systemic agents.”
