Apogee Therapeutics Announces Results Up to 9 Months from Phase 1 Trial of APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases

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Apogee Therapeutics
Apogee Therapeutics

Pharmacokinetic data up to 9 months continue to support potential best-in-class profile, including a half-life of approximately 75 days, approximately three to five times that of currently approved treatments for moderate-to-severe AD

Key biomarker data from single doses of APG777 show near complete inhibition of pSTAT6 and sustained TARC inhibition up to 9 months

Proof-of-concept data from the ongoing APG777 Phase 2 clinical trial in patients with moderate-to-severe atopic dermatitis are expected in 2H 2025

APG777 has the potential to demonstrate improved clinical responses from greater exposures in induction and maintenance dosing of every 3- or 6-months

SAN FRANCISCO and WALTHAM, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced updated positive results from its ongoing Phase 1 clinical trial of APG777, a novel half-life extended anti-IL-13 antibody for the treatment for atopic dermatitis and other inflammatory diseases, in healthy volunteers up to nine months. These data will be presented at the American College of Allergy, Asthma & Immunology’s (ACAAI) 2024 Annual Scientific Meeting, held in Boston from October 24-28, 2024.

Today’s results build on the Phase 1 positive interim data announced in March 2024. This updated dataset includes findings from the 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. Findings demonstrated that 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 Cmax and 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.