Apogee Therapeutics reports positive 52-week Phase 2 APEX trial results for zumilokibart in moderate-to-severe atopic dermatitis, showing durable responses with 3- and 6-month dosing.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Apogee Therapeutics has reported positive 52-week maintenance results from Part A of the Phase 2 APEX clinical trial (NCT06395948) evaluating zumilokibart (APG777) in patients with moderate-to-severe atopic dermatitis (AD), demonstrating durable disease control with infrequent dosing schedules.
The study showed that patients maintained strong clinical responses with both every-3-month and every-6-month dosing regimens, while efficacy continued to deepen across lesion and itch endpoints over the full treatment period. These findings highlight the potential of zumilokibart to provide long-lasting disease control with significantly fewer injections compared with currently available therapies.
Zumilokibart is a novel, subcutaneous monoclonal antibody designed with an extended half-life to target interleukin-13 (IL-13), a key cytokine driving inflammation in atopic dermatitis. By achieving greater than 99% inhibition of IL-13, the therapy is intended to reduce inflammation and rapidly improve skin lesions and itching associated with the disease.
In the 52-week maintenance phase, patients received 360 mg of zumilokibart with either quarterly or biannual dosing. Among patients who responded at Week 16, 75% and 85% maintained EASI-75 responses with 3-month and 6-month dosing, respectively.
Investigator’s Global Assessment (vIGA) scores of 0 or 1 were maintained in 86% of patients receiving quarterly dosing and 78% receiving biannual dosing. Across the full treated population, improvements in both lesion severity and itch continued to deepen through one year of therapy.
Zumilokibart was generally well tolerated over the 52-week period, with a safety profile consistent with other therapies in the IL-13 inhibitor class. The most commonly reported treatment-emergent adverse events included non-infective conjunctivitis, upper respiratory tract infection, and nasopharyngitis.
Atopic dermatitis is a chronic inflammatory skin disorder that can cause persistent itching, sleep disturbances, psychological stress, and increased infection risk, significantly affecting quality of life. Current biologic treatments often require frequent injections, which may reduce long-term treatment adherence. The ability to administer zumilokibart as few as two to four times per year could represent a meaningful shift in treatment convenience and patient compliance.
Apogee is also exploring broader indications for the therapy. The drug has demonstrated proof-of-concept in asthma and may expand into additional inflammatory and immunology conditions such as eosinophilic esophagitis (EoE).
Further development is ongoing. Part B of the APEX study, a placebo-controlled dose-optimization trial enrolling 347 patients, is expected to report 16-week results in the second quarter of 2026. Based on these findings, Apogee plans to initiate Phase 3 trials in the second half of 2026, with a potential commercial launch targeted for 2029, pending regulatory approval.
References
Apogee Therapeutics Announces Positive Phase 2 Part A 52-Week Data of Zumilokibart (APG777), Demonstrating Maintenance and Deepening of Responses with Every 3- and 6-Month Dosing in Moderate-to-Severe Atopic Dermatitis, 23 March 2026, Apogee Therapeutics Announces Positive Phase 2 Part A 52-Week Data of Zumilokibart (APG777), Demonstrating Maintenance and Deepening of Responses with Every 3- and 6-Month Dosing in Moderate-to-Severe Atopic Dermatitis | Apogee Therapeutics, Inc.
A Study Evaluating APG777 in Atopic Dermatitis, ClinicalTrials.gov ID NCT06395948, https://clinicaltrials.gov/study/NCT06395948
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.