Apogee Teases 72% EASI-75 Durability, Six-Month Dosing in Phase III

APGEAPGE

Apogee will report 52-week maintenance data for its atopic dermatitis treatment zumilokibart this month, testing quarterly and six-month dosing with responder benchmarks near 72% for EASI-75 and 53% for IGA 0/1. Phase III is slated to start by year-end with Part B higher-dose readouts due in Q2.

1. 52-Week Durability Data Tease

Apogee reiterated its intent to present 52-week maintenance results for Zumi this month, randomizing all patients into quarterly and six-month regimens. The analysis will benchmark approximately 72% EASI-75 and 53% IGA 0/1 maintenance rates against established biologics, providing a fuller picture of long-term durability.

2. Phase III Plans and Financing

Management plans to initiate two Phase III replicate placebo-controlled trials by year-end, with a third trial including topical corticosteroids to support label indications. The company is funded into the second half of 2028 and targets a 2029 launch for Zumi, aiming to reduce treatment burden with infrequent dosing.

3. Part B High-Dose Study

Part B data are expected in Q2 to evaluate a higher-dose maintenance regimen, leveraging exposure-response insights from Part A and external IL-13 studies. The study will assess whether increased exposure can deliver incremental efficacy gains beyond the mid-dose regimen, with roughly five percentage points viewed as clinically meaningful.

4. Safety Profile and Pipeline Expansion

Safety observations focus on transient conjunctivitis events lasting under 30 days, with no head and neck erythema or eosinophilia reported. Apogee also highlighted its next-generation pipeline, including head-to-head data for OX40 ligand blocker APG279 versus Dupixent and designs for asthma and eosinophilic esophagitis studies later this year.

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