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Apogee Therapeutics Announces First Patient Dosed in Part B of Phase 2 APEX Trial of APG777 in Patients with Moderate-to-Severe Atopic Dermatitis
Enrollment of Part A completed ahead of schedule and exceeded enrollment target with 123 patients enrolled Part A 16-week proof-of-concept data anticipated in
About this update from Apogee Therapeutics, Inc.
[{"type":"text","content":"Enrollment of Part A completed ahead of schedule and exceeded enrollment target with 123 patients enrolled Part A 16-week proof-of-concept data anticipated in mid-2025 SAN FRANCISCO and BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other I&I indications, today announced the first patient has been dosed in the Part B portion of the Phase 2 APEX clinical trial of APG777 in patients with moderate-to-severe AD, as well as enrollment completion in the Part A portion of the trial. “Enrollment for the Phase 2 Part A trial of APG777 surpassed the approximately 110 patient target ahead of schedule, driven by strong patient and investigator enthusiasm, underscoring the potential of APG777 to address the need for safe, effective treatment options that reduce injection burden and provide better disease control for patients with AD and other I&I conditions,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “Positive results from our Phase 1 healthy volunteer trial enabled us to design this Phase 2 trial whereby APG777 is modeled to exceed lebrikizumab exposures by ~30-40% with potential for improved clinical responses, as well as approximately half the number of injections during induction and ~70-90% fewer injections in maintenance compared to currently available therapies. Our uniquely designed Phase 2 trial allowed us to seamlessly transition from completing enrollment in Part A to enrolling Part B within one week, streamlining the clinical development process and potentially enabling us to bring APG777 to patients sooner.” APEX is a Phase 2 randomized, placebo-controlled clinical trial evaluating APG777, a novel, subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD, 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 exceeded expected enrollment with 123 patients randomized 2...