Apogee Therapeutics (APGE) Study Result summary

Study overview and objectives

• Phase II APEX Part A evaluated APG-777 in 123 adults with moderate-to-severe atopic dermatitis, using a regimen designed for higher exposure and fewer injections than competitors, with induction dosing at weeks 0, 2, 4, and 12.

• The primary endpoint was least squares mean percent change from baseline in EASI score at week 16; secondary endpoints included EASI-75, EASI-90, vIGA 0/1, and itch reduction.

• Patients were randomized 2:1 to APG-777 or placebo, with robust statistical methods including multiple imputation for missing data.

• The study aimed to test if higher exposures could enable quarterly or better dosing and improve efficacy over existing biologics.

• Maintenance dosing intervals of every 3 or 6 months are being evaluated, with 52-week data expected in the first half of 2026.

Key efficacy results

• APG-777 met the primary endpoint with a 71.0% mean reduction in EASI score at week 16 versus 33.8% for placebo (p<0.001), surpassing results from Dupixent and lebrikizumab.

• 66.9% of patients achieved EASI-75 at week 16, with a placebo-adjusted rate of 42.5%, the highest reported for any biologic in global studies.

• Statistically significant improvements were seen in EASI-90 and vIGA 0/1, with rapid onset of action and significant itch relief by week 1.

• Efficacy was robust across moderate and severe subgroups, and higher drug exposure correlated with greater clinical benefit.

• Sensitivity analyses confirmed consistent efficacy, and APG-777 provided fast and deep itch relief, with >50% decrease by week 16 without topical corticosteroids.

Exposure-response and dose optimization

• Strong exposure-response relationship observed, with highest EASI-75 rates (83.3% and 89.5%) in top two exposure quartiles.

• APEX Part B is ongoing, testing higher exposures (up to 90%-100% greater than lebrikizumab) to match top responder levels, with topline data expected mid-2026.

• Maintenance dosing could be as infrequent as every 3–6 months, potentially reducing annual injections to 2–4.

• All patients in maintenance will receive active treatment, with blinding maintained via placebo injections.

• Dose optimization aims to enable best-in-class quarterly or better maintenance dosing.