Apogee Therapeutics announces updated results from Phase 1 trial of APG777

Apogee Therapeutics (APGE) 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. Key Findings from the Phase 1 APG777 Results Up to 9 Months: Dose proportional PK was observed, with a half-life of ~75 days, approximately three to five times that of currently approved treatments for moderate-to-severe AD consistent with previously reported interim results; APG777 demonstrated dose proportional increases in Cmax and AUC from 300mg up to 1,200mg across all SAD and MAD cohorts. Single and multiple doses of APG777 resulted in rapid and sustained effect on PD markers for up to nine months; Single doses of APG777 showed rapid, near-complete inhibition of pSTAT6, one of the first downstream markers of IL-13 pathway inhibition, up to nine months; MAD cohorts showed similar inhibition of pSTAT6 through available follow-up. APG777 was generally well-tolerated at doses up to 1,200 mg; Treatment-emergent adverse events were generally mild-to-moderate and unrelated to APG777; there were no serious adverse events or dose-dependent trends observed up to time of data cut