Apogee Therapeutics Announces Positive 16-Week Part B Induction Dose Optimization Results from Phase 2 APEX Trial of Zumilokibart in Moderate-to-Severe Atopic Dermatitis

About this update from Apogee Therapeutics, Inc.

APEX Part B met all primary and secondary endpoints with high statistical significance; mid-dose zumilokibart planned to advance into Phase 3 trials in moderate-to-severe atopic dermatitis (AD) in 2H 2026 Zumilokibart was well tolerated with a safety profile consistent with other agents in class Strategic financing collaboration with Blackstone Life Sciences announced today expected to provide funding through commercialization of zumilokibart in AD, asthma, and EoE Results support pipeline-in-a-product potential for zumilokibart with asthma and eosinophilic esophagitis (EoE) trial plans shared today Management to host conference call today at 8:00 a.m. ET SAN FRANCISCO and BOSTON , May 27, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced positive 16-week data from Part B of the Phase 2 APEX clinical trial of zumilokibart (APG777), a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe AD. The trial met its primary and secondary endpoints with high statistical significance including 65.9% of patients treated with mid-dose zumilokibart achieving EASI -75 (41.9% placebo adjusted). Based on these dose optimization results and subject to regulatory interactions, Apogee plans to move forward with the mid-dose, which achieved the best clinical activity of the three doses tested and was well-tolerated, in its Phase 3 trials. "We are thrilled by the strength and consistency that zumilokibart demonstrated across all endpoints from today's APEX Part B induction results, which we believe could set a new standard of care for patients. Today’s results help clear our path to advance zumilokibart into the Phase 3 trials planned for the second half of this year and we look forward to engaging with regulatory agencies.” said Michael Henderson, M.D., Chief Executive Officer of Apogee. "Zumilokibart has the potential to move the bar on disease control and dosing based on both today's data as well as the robust APEX Part A maintenance results that showed continued improvement in efficacy over 52 weeks with every 3- and 6- month dosing. Beyond AD, we are excited to develop zumilokibart's pipeline-in-a-product potential and plan to commence Phase 2 studies in EoE in the second half of 2026 and asthma in the first half of 2027." “Patients with atopic dermatitis and their physicians want therapies that provide durable and deeper disease control with less frequent dosing. The APEX Part B results align extremely well with these patient-centric goals, particularly the achievement of very low disease activity, or vLDA, with simultaneous robust improvement in lesion and itch benefit in more than one fifth of mid-dose patients, which are results not seen with any biologic to date,” said Ruth Ann Vleugels , MD, MPH, MBA, Heidi and Scott C. Schuster Distinguished Chair in Dermatology and Director, Atopic Dermatitis Program at Mass General Brigham and Professor of Dermatology, Harvard Medical School . “The Part B induction data demonstrated that zumilokibart delivered robust efficacy within the first 16 weeks with significantly fewer injections versus the current standard-of-care. Together with Part A data demonstrating that zumilokibart can be dosed every 3 to 6 months in maintenance with continuous and even enhanced efficacy, we are seeing a strong clinical profile that offers what dermatologists are looking for in clinical practice for our patients.” APEX Phase 2 Part B 16-Week Results The Phase 2 APEX clinical trial is a randomized, placebo-controlled study evaluating zumilokibart in patients with moderate-to-severe AD. In Part B, 346 adult patients were dosed after being randomized 1:1:1:1 to high-, mid- or low-dose zumilokibart versus placebo. The primary endpoint is the proportion of patients who achieve an Eczema Area and Severity Index (EASI) percent score reduction of at least 75 ( EASI -75) at Week 16. Secondary endpoints include Validated Investigator’s Global Assessment (IGA) 0/1, EASI -90, Itch Numeric Rating Scale (I-NRS ≥4), EASI -100, and Very Low Disease Activity (vLDA; EASI -90 + I-NRS 0/1) at Week 16. The trial met its primary endpoint, with mid- and high-doses of zumilokibart demonstrating comparable efficacy and both doses outperforming low dose and placebo with EASI -75 scores at Week 16: High dose: 61.6% achieved EASI -75 (p

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