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 - Seite 2

The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG808 and is expected to enroll approximately 32 healthy adults into four cohorts. Apogee expects interim data from the trial in the second half of 2024, and, pending positive results from the Phase 1 trial and following the submission of an IND or foreign equivalent, plans to initiate a potential Phase 1b trial in asthma with a data readout in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.

“By targeting known biologic drivers of disease and utilizing advanced antibody engineering such as improved half-life, Apogee aims to overcome limitations of existing therapies for I&I diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We demonstrated the potential benefits of optimizing antibody properties with APG777 and now hope to do the same with APG808, which, in head-to-head preclinical studies, demonstrated similar potency to current therapies but with a significantly longer half-life. Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”

About APG808
APG808 is a novel, subcutaneous extended half-life monoclonal targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases, for the potential treatment of chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology indications. 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. A Phase 1 clinical trial of APG808 in healthy volunteers is ongoing, and the company expects interim safety and pharmacokinetic data in the second half of 2024. Pending data from the Phase 1 trial, the company plans to initiate a potential Phase 1b trial in asthma with a data readout in in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.