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]

Core Insights - APG777 has shown significant efficacy in treating moderate-to-severe atopic dermatitis, achieving a 71.0% reduction in EASI from baseline at Week 16, surpassing the placebo group which had a 33.8% reduction [1][9] - The drug demonstrated an EASI-75 response rate of 66.9%, the highest for any biologic in a global study, with a placebo-adjusted rate of 42.5% [1][3][9] - A favorable safety profile was observed, with serious treatment-emergent adverse events being rare at 1.2% compared to 2.4% in the placebo group [9] Clinical Trial Results - The Phase 2 APEX trial Part A enrolled 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] - Key secondary endpoints included EASI-90 and Validated Investigator Global Assessment (IGA) 0/1, with EASI-90 achieving 33.9% compared to 14.7% in placebo (p < 0.05) and vIGA 0/1 at 34.9% compared to 17.3% in placebo (p < 0.05) [9] - Rapid onset of itch relief was noted, with a 50.7% reduction in Itch NRS from baseline by Week 1 compared to 23.2% in the placebo group (p < 0.01) [9] Future Developments - APEX Part B is set to test higher doses of APG777, with results expected in mid-2026, while the maintenance phase readout from Part A is anticipated in the first half of 2026 [1][6] - The company is also conducting a Phase 1b trial of APG279, a combination therapy, with readout expected in the second half of 2026 [2][3] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including atopic dermatitis [2][8] - The company aims to optimize efficacy and dosing through advanced antibody engineering, targeting well-established mechanisms of action [8][10]