Evommune (EVMN) Study result summary

Study overview and rationale

• EVO301 is a long-acting fusion protein designed to neutralize IL-18, a cytokine implicated in multiple inflammatory pathways relevant to atopic dermatitis and other chronic diseases.

• The phase 2A trial was a randomized, double-blind, placebo-controlled study in adults with moderate to severe atopic dermatitis, enrolling 70 patients at 12 sites in Australia and New Zealand, with 65 completing the trial.

• Patients received two IV doses of 5 mg/kg at day 1 and 28 (weeks 0 and 4), with follow-up through week 12.

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

• The trial aimed to validate IL-18 as a therapeutic target and assess the efficacy and safety of EVO301.

Efficacy results

• The primary endpoint (percent change from baseline in EASI at week 12) was met with a Bayesian posterior probability of 99.76% that the true difference between EVO301 and placebo was at least 8%.

• Statistically significant EASI reductions were observed 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 an IGA score of 0 or 1 at week 12, compared to 0% in placebo.

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

• Efficacy was durable, with meaningful improvements sustained eight weeks after the last dose.

Safety and tolerability

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

• Adverse event rates were similar between EVO301 and placebo groups; most common events included upper respiratory tract infection, atopic dermatitis, and headache.

• No clinically significant lab abnormalities or conjunctivitis were observed.

• Five discontinuations occurred (two active, three placebo), all unrelated to adverse events.

• The safety profile supports potential for higher or more frequent dosing in future studies.