Apogee Therapeutics, Inc. APG777 continues to show promise in atopic dermatitis (AD), according to early data.
APG777 is a novel half-life extended anti-interleukin (IL)-13 antibody under development for the treatment for AD and other inflammatory diseases.
Pharmacokinetic data up to 9 months show a half-life of approximately 75 days, approximately three to five times that of currently approved treatments for moderate-to-severe AD. near-complete inhibition of pSTAT6 and sustained TARC inhibition out to nine months following a single dose
These data will be presented at the American College of Allergy, Asthma & Immunology’s (ACAAI) 2024 Annual Scientific Meeting in Boston, MA.
This new dataset includes findings from 40 enrolled participants across three single-ascending dose (SAD) cohorts, now with nine months of follow-up, and two multiple-ascending dose (MAD) cohorts, now with six months of follow-up.
APG777, in single doses up to 1,200mg or multiple doses of 300mg, showed a well-tolerated safety profile. Pharmacokinetic (PK) data was consistent with what was previously reported, including a half-life of approximately 75 days, dose proportional increases in the maximum concentration (Cmax) and Area Under Curve (AUC), and low variability.
APG777’s pharmacodynamic (PD) profile showed near complete inhibition of pSTAT6 and sustained TARC inhibition up to 9 months.
These findings further support Apogee’s ongoing Phase 2 clinical trial of APG777 in patients with moderate-to-severe AD, with the potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing in maintenance at every three or six months compared to every two-to-four-week dosing with currently approved biologic therapies. The company expects to report 16-week topline data from Part A of the trial in the second half of 2025.
