Apogee Announces Dosing of First Patient in Phase 2 Atopic Dermatitis Trial of APG777, a Novel Subcutaneous Half-life Extended Anti-IL-13 Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile

16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025

Pipeline-in-a-product potential with a Phase 2 in asthma expected to initiate in 2025 and plans for additional indication expansion

SAN FRANCISCO and WALTHAM, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing in the Phase 2 trial of APG777 in patients with moderate-to-severe atopic dermatitis. APG777 is a novel, subcutaneously-administered half-life extended monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD.

“We are thrilled to begin patient dosing in our Phase 2 trial of APG777, marking a significant step forward in the advancement of this program and to further realizing the impact a fully-optimized antibody with extended half-life could have on the treatment of AD compared to other available biologics,” said Michael Henderson, MD, Chief Executive Officer of Apogee. “The initiation of this Phase 2 trial is supported by the highly encouraging results of our Phase 1 healthy volunteer trial that were reported earlier this year. With a potentially best-in-class pharmacokinetic profile, sustained pharmacodynamic responses, and well-tolerated safety profile, we believe APG777 could offer improved clinical responses with less frequent dosing than current standard of care. We look forward to the advancement of this trial and initial 16-week data in the second half of 2025.”

The APG777 Phase 2 clinical trial is a randomized, placebo-controlled, 16-week trial in patients with moderate-to-severe AD. The trial was designed to combine the typical Phase 2a and 2b portions of a clinical trial into a single protocol. Part A is expected to enroll approximately 110 patients randomized 2:1 to APG777 vs. placebo; patients receiving APG777 will receive induction regimen dosing of 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12. Patients benefiting from treatment will continue to APG777 maintenance, which will evaluate 3- to 6-month dosing. Part B is a placebo-controlled dose optimization with approximately 360 patients randomized 1:1:1:1 to high, medium, or low dose APG777 vs. placebo. The primary endpoint of each part of the study is mean percentage changes in EASI score from baseline to Week 16.