Apogee Therapeutics Announces Positive 16-Week Data from Phase 2 APEX Clinical Trial of APG777, its Potentially Best-in-Class Anti-IL-13 Antibody, in Moderate-to-Severe Atopic Dermatitis

Core Insights - Apogee Therapeutics announced positive results from the Phase 2 APEX clinical trial of APG777, demonstrating significant efficacy in treating moderate-to-severe atopic dermatitis [2][3][4] Group 1: Trial Results - APEX Part A met all primary and key secondary endpoints, achieving a 71.0% decrease in Eczema Area Severity Index (EASI) from baseline at Week 16 [1][9] - APG777 showed an EASI-75 response rate of 66.9%, which is the highest reported for any biologic in a global study, with a placebo-adjusted rate of 42.5% [1][3][9] - The trial included 123 adult patients, randomized 2:1 to receive APG777 or placebo, with a dosing regimen of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12 [4][9] Group 2: Safety and Tolerability - APG777 was well tolerated, with a safety profile consistent with other agents in its class, and serious treatment-emergent adverse events (TEAEs) were rare at 1.2% compared to 2.4% in the placebo group [1][9] - The discontinuation rate due to adverse events was low at 2.4% for APG777-exposed patients [9] Group 3: Future Developments - APEX Part B is set to test higher doses of APG777, with readout expected in mid-2026, and the initiation of a Phase 3 trial planned for 2026 [1][3][6] - The company is also conducting a Phase 1b head-to-head trial of APG279 against DUPIXENT, with results anticipated in the second half of 2026 [1][3]