Apogee Therapeutics (APGE) Study result summary

Study design and objectives

• APEX Part B was a randomized, dose-ranging phase II trial in 346 moderate-to-severe atopic dermatitis patients, comparing low, mid, and high doses of zumilokibart versus placebo to identify the optimal dose for phase III advancement.

• Patients enrolled had EASI ≥16, vIGA ≥3, and BSA ≥10%, with well-balanced baseline demographics.

• Dosing intervals included every 3 or 6 months, with only 4 induction doses and 2–4 maintenance doses per year.

• Patients were re-randomized into three- or six-month maintenance dosing arms, with maintenance data to be released next year.

• The trial aimed to maximize IL-13 inhibition efficacy while maintaining a favorable safety profile and minimizing injection burden.

Key efficacy results

• The primary endpoint, EASI-75 at week 16, was met with 65.9% (mid-dose) achieving response versus 23.4% for placebo (p<0.001).

• Mid-dose showed robust results on higher-order endpoints: 46% achieved IGA 0/1, 47.4% achieved EASI-90, and 16.5% achieved EASI-100 at week 16.

• Over half of mid-dose patients achieved a ≥4-point reduction in itch NRS at week 16.

• Lesion reduction was observed as early as Week 1, with robust and continuous improvement across all endpoints.

• Results were consistent with Part A and compared favorably to existing biologics and JAK inhibitors in non-head-to-head analyses.

Safety and tolerability

• Zumilokibart was well-tolerated, with adverse events in line with the IL-13/IL-4 class; most common were nasopharyngitis, headache, conjunctivitis, URTI, atopic dermatitis, and UTI.

• Non-infective conjunctivitis rates were 5.9% (mid-dose), with pooled conjunctivitis-related events at 10.6%, similar to standard of care.

• Serious TEAEs and discontinuations due to TEAEs were low and similar to placebo, with an overall discontinuation rate of 6%.

• No effect of anti-drug antibodies on pharmacokinetics, efficacy, or safety was observed.