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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 o...
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
About this update from Apogee Therapeutics, Inc.
[{"type":"text","content":"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 Schedule with Half-Life of Approximately 75 Days \n 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. T...