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

The first volunteers have been dosed in a Phase 1 trial for Apogee Therapeutics, Inc.’s APG777 for moderate-to-severe atopic dermatitis (AD) and other inflammatory diseases. 

APG777 is a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13. 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. 

The APG777 Phase 1 trial is a double-blind, placebo-controlled study in healthy volunteers and consists of a single-ascending dose (SAD) component and a multiple-ascending dose (MAD) component. The study is expected to enroll approximately 40 healthy adult subjects into three SAD and two MAD cohorts. The primary endpoint is safety, and a key secondary endpoint is pharmacokinetics (PK). 

Initial safety and PK data from this trial should be available by mid-2024. Pending data from the Phase 1 trial, Apogee plans to initiate a randomized, placebo-controlled, 16-week Phase 2 clinical trial in patients with moderate-to-severe AD in 2024.

“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,” says Michael Henderson, M.D., Chief Executive Officer of Apogee, in a news release. “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.”