Evommune (EVMN) Study result summary

Study overview and rationale

• Phase 2a proof-of-concept trial of EVO301 in moderate-to-severe atopic dermatitis enrolled 70 adults in a randomized, double-blind, placebo-controlled design at 12 sites in Australia and New Zealand.

• Patients received two IV doses of 5 mg/kg EVO301 or placebo at weeks 0 and 4, with follow-up through week 12.

• Baseline demographics and disease characteristics were well-balanced, with no prior biologic exposure.

• The primary endpoint was percent change from baseline in EASI at week 12, analyzed using a Bayesian approach.

• The trial included secondary efficacy and pharmacokinetic/pharmacodynamic assessments.

Efficacy results

• Achieved a Bayesian posterior probability of 99.76% that EVO301 outperformed placebo by at least 8% in EASI score at week 12, far exceeding the 75% success threshold.

• Statistically significant EASI reductions versus placebo at weeks 4, 8, and 12, with placebo-adjusted improvements of 34% and 33% at weeks 8 and 12, respectively.

• 23% of EVO301 patients achieved IGA 0/1 at week 12 versus 0% for placebo, with rapid and durable efficacy after only two doses.

• Efficacy at 12 weeks was comparable to dose-optimized marketed biologics at 16 weeks, based on EASI improvement.

• Secondary endpoints and biomarker reductions (TH2 and non-TH2 cytokines) supported broad anti-inflammatory activity.

Safety and pharmacokinetics

• EVO301 was well tolerated, with no treatment-related serious or severe adverse events and no treatment-related discontinuations.

• Adverse event rates were similar between groups; most common events included upper respiratory tract infection, atopic dermatitis, and headache.

• No clinically significant lab abnormalities or conjunctivitis were observed.

• Pharmacokinetics and target engagement support a Q4 week dosing regimen, with robust and sustained IL-18 neutralization.

• Only two doses were administered in phase 2A, but future phase 2B will explore higher and/or more frequent dosing, including subcutaneous formulations.