Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Pharmacokinetic data support potential best-in-class profile with potential for improved clinical responses from greater exposures in induction than currently available biologic therapies and maintenance dosing of every 3- or 6-months

Single dose showed deep and sustained inhibition of key atopic dermatitis biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available with inhibition still ongoing at time of data cut)

APG777 was well tolerated with a favorable safety profile consistent with the anti-IL-13 class

Company plans to initiate a randomized, placebo-controlled, 16-week Phase 2 clinical trial in patients with moderate-to-severe atopic dermatitis in 1H 2024 with induction regimen designed to exceed lebrikizumab exposures by ~30-40% and every 3- or 6- month maintenance dosing

High dose concentration of 180 mg/mL will enable 44% higher dose than lebrikizumab in the same volume

Management will host a webcast and conference call today at 7:00 a.m. ET

SAN FRANCISCO and WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease, asthma and other inflammatory and immunology (I&I) indications, today announced positive interim Phase 1 data from its first-in-human study of APG777, one of its lead product candidates being developed as a frontline treatment for moderate-to-severe AD and other inflammatory diseases. Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested and Pharmacodynamic (PD) data showed deep and sustained inhibition of key AD biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at time of the data cut).

Results from the trial exceeded the Company’s trial objectives and support the potential for APG777, a novel anti-IL-13 antibody, to optimize exposure levels in 16-week induction and be dosed once every three or six months in maintenance. These findings represent the potential for improved clinical responses from greater exposures in induction and significantly less frequent dosing in maintenance compared to currently approved biologic therapies, which are dosed at every two to four weeks, a potential major advancement for patients with AD and other inflammatory diseases. APG777, in single doses up to 1,200mg and multiple doses of 300mg, was well tolerated and showed a favorable safety profile, in line with the existing body of third-party evidence for the safety of the anti-IL-13 class. Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.