Apogee Therapeutics Announces First Participants Dosed in Phase 1 Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) and Other Inflammatory Diseases

Preclinical data with APG808 demonstrate the potential for improved dosing over other treatment options in development, including the potential for dosing every six- or eight- weeks compared to dosing every two weeks for other biologics in development

Second product candidate to enter the clinic following positive interim results from Phase 1 Healthy Volunteer Trial for APG777, which exceeded all of its trial objectives

Interim subcutaneous safety and pharmacokinetic data from healthy volunteers anticipated in 2H 2024

SAN FRANCISCO and WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.

“On the heels of announcing positive interim data from our Phase 1 APG777 clinical trial, the initiation of the APG808 Phase 1 healthy volunteer trial represents another important advancement for Apogee’s portfolio of differentiated and optimized biologics,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Launching our second clinical program, ahead of initial timeline expectations, brings us one step closer to providing potentially best-in-class biologics designed to significantly improve therapeutic options for patients with I&I diseases and further builds our track record of execution.”

APG808 is a novel, SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to a first-generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays, which measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older. Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.