Apogee Announces First Participants Dosed Ahead of Schedule in Phase 1 Trial of APG777, its Novel Half-life Extended Anti-IL-13 Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

Preclinical data with APG777 demonstrate the potential for significantly improved dosing over standard of care, including the potential for every two- or three-month dosing

Initial subcutaneous pharmacokinetic and safety data from healthy volunteers anticipated in mid-2024

First product candidate to enter the clinic from the company’s strategic collaboration with Paragon Therapeutics, Inc., an innovative discovery engine developing potentially best-in-class biologics

SAN FRANCISCO and WALTHAM, Mass., Aug. 07, 2023 (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 and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG777, its lead product candidate being developed as a frontline treatment for moderate-to-severe AD and other inflammatory diseases. Initiation of this trial marks a milestone for the company and its approach. By targeting known biologic drivers of disease and utilizing advanced antibody engineering to develop product candidates with optimized properties such as improved half-life, Apogee aims to overcome the limitations of existing therapies for (I&I) diseases.

“The initiation of this Phase 1 study of APG777 represents an important advancement for Apogee, now a clinical-stage organization, and for our discovery research collaboration with Paragon, a pioneer in developing best-in-class biologics for a range of diseases,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “By leveraging known targets with differentiated monoclonal antibodies, Apogee has the potential to improve the course of treatment for multiple inflammatory disorders, and APG777 is just the start of our strategy to develop a broad pipeline of potentially best-in-class product candidates. I am proud of the Apogee team's rapid progress in advancing APG777 to this new stage, ahead of our initial timeline expectations.”

APG777 is a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. In head-to-head preclinical studies, APG777 demonstrated equivalent or better potency to lebrikizumab in the inhibition of IL-13 signaling and exhibited significantly longer half-life with the potential to deliver dosing as infrequently as once every two to three months. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Today’s treatments are associated with many challenges, including frequent injection regimens that can lead to poor patient compliance.