Clinical-stage biotechnology company Apogee Therapeutics has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous extended half-life monoclonal antibody (mAb) targeting IL-4Ra, which is being developed as a treatment for COPD, asthma and other diseases.
The company said IL-4Ra is a target with clinical validation across eight type-2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Ra 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.
“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 (these) diseases,” said Chief Medical Officer of Apogee Carl Dambkowski, MD. “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.”
The APG808 phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. It will evaluate the safety, tolerability and pharmacokinetics of APG808 and is expected to enroll approximately 32 adults into four cohorts. Apogee expects interim data from the trial in the second half of 2024, and, pending those results, is planning a potential phase 1b trial in asthma patients in the first half of 2025, followed by a phase 2 trial in COPD patients in 2025.
