Apogee Therapeutics said Monday that APG777, its long-acting anti-IL-13 antibody for moderate-to-severe atopic dermatitis, met all primary and key secondary endpoints in Part A of the 123-patient Phase 2 APEX study. After 16 weeks, patients on APG777 recorded a 71.0% mean reduction in the Eczema Area and Severity Index, versus 33.8% for placebo. Two-thirds of treated participants achieved the EASI-75 benchmark, and itch scores fell by roughly 51% within a week. The drug was generally well tolerated; non-infective conjunctivitis occurred in 15% of treated patients, and no injection-site reactions were reported. The company will test higher exposures in Part B of APEX, expected to read out in mid-2026, and plans to begin Phase 3 trials that same year. With quarterly or semi-annual dosing, Apogee aims to position APG777 as a convenience challenger to current market leaders Dupixent and Eli Lilly’s Ebglyss. Apogee shares rose about 20% in early trading. Separately, KalVista Pharmaceuticals won U.S. Food and Drug Administration approval for EKTERLY (sebetralstat), the first oral on-demand treatment for hereditary angioedema. The company said it will launch the medicine immediately; its stock advanced roughly 19% on the announcement. The dual milestones mark an active day in inflammatory and immunology therapeutics, highlighting investor appetite for novel dosing regimens and patient-friendly administration routes across common and rare conditions.
$APGE conjunctivitis rate of 15% is not that significant. This is not a serious problem and it could be an aberration here given the small sample size If conjunctivitis risk correlates with efficacy as on target/class effect it is actually a good sign for the future Trials. If https://t.co/KOisXP9oIv
Apogee's eczema candidate passes Phase 2 test, the company said today, posing potential convenience competition to Sanofi’s Dupixent and Eli Lilly’s Ebglyss. https://t.co/7x7UD31VZD
$APGE Apogee premarket is $xbi investing in a nutshell.