Apogee announces first participants dosed in Phase 1 trial of APG808

Apogee Therapeutics announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous extended half-life monoclonal antibody targeting IL-4Ralpha, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases. APG808 is a novel, SQ extended half-life mAb targeting IL-4Ralpha, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Ralpha 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. 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.