Core Insights - Apogee Therapeutics, Inc. announced that data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis will be presented at the EADV Congress 2025 in Paris, highlighting its potential as a best-in-class treatment [1][2] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease [4][5] - The company aims to create best-in-class profiles through advanced antibody engineering and targeting established mechanisms of action [4][5] Clinical Trial Highlights - The APEX trial demonstrated that APG777 met both primary and secondary endpoints, reinforcing its potential as a leading treatment option for moderate-to-severe atopic dermatitis [2] - APG777 is notable for being the only biologic tested with maintenance dosing every 3 and 6 months [2] - The combination of APG777 with APG990, which targets OX40L, is expected to broaden the treatment scope for various inflammatory conditions [2] Presentation Details at EADV Congress 2025 - A late-breaker oral presentation titled "APG777, a Novel, Half-Life Extended Anti-IL-13 Antibody, Demonstrates Safety and Efficacy in Moderate-to-Severe Atopic Dermatitis: 16-Week Results from the Phase 2 APEX Study" will be presented by Dr. Emma Guttman-Yassky on September 19, 2025 [3] - Multiple poster presentations will also be featured, including studies on APG777 and APG990, showcasing their safety profiles and efficacy [3]

Core Insights - Apogee Therapeutics reported positive results from the 16-week Phase 2 Part A APEX trial for APG777, an anti-IL-13 antibody, which met all primary and key secondary endpoints for moderate-to-severe atopic dermatitis [1][2][3] - The company is advancing its pipeline with ongoing trials, including a Phase 1b head-to-head study of APG279 against DUPIXENT, with results expected in the second half of 2026 [1][2][3] - Apogee has a strong cash position of $621.2 million, which is projected to support operations into Q1 2028 [1][6][8] Pipeline Progress - APG777 demonstrated a 71.0% reduction in the Eczema Area and Severity Index (EASI) from baseline compared to 33.8% for placebo (p < 0.001) in the APEX Part A trial [3][4] - The APEX Part A maintenance phase is testing dosing every 3- and 6-months, potentially allowing for 2-4 injections per year versus 26 for standard care [3][7] - The readout for APEX Part B has been accelerated to mid-2026 due to strong enrollment [1][2][3] Financial Performance - Research and development expenses increased to $55.7 million for Q2 2025, up from $33.2 million in Q2 2024, primarily due to the development of APG777 [6][8] - General and administrative expenses rose to $17.5 million in Q2 2025 from $10.9 million in Q2 2024, driven by increased personnel-related costs [6][8] - The net loss for Q2 2025 was $66.1 million, compared to a net loss of $33.8 million in Q2 2024, reflecting higher operating expenses [8][15]

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]

Pipeline and Clinical Development - Apogee plans to transform the standard-of-care for I&I diseases with novel antibodies and combination approaches [6] - APG777 Phase 2 Part A is fully enrolled, with a readout expected in mid-2025, potentially demonstrating best-in-class efficacy [8, 33] - APG279, a combination of APG777 and APG990, is expected to initiate a Phase 1b trial against DUPIXENT in 2025, with a readout expected in 2H 2026 [6, 19] - APG777+APG333 clinical planning is underway for asthma and COPD [19] - Apogee has 7 clinical trial readouts expected over the next 2 years [105] Financial Position - Apogee has $681 million in total cash, providing an expected runway into Q1 2028 [7, 105] Market Opportunity - The atopic dermatitis (AD) market is projected to be a future $50B+ market [7, 17, 25, 90] - Mature I&I markets have consistently achieved high biologics penetration, approximately 25-60% after 15-20 years [9] - In 2024, the worldwide market size for IBD was $24B, RA was $24B, PsO was $29B [10] APG777 Potential - APG777 has the potential for annual dosing due to its optimized PK profile and 77-day half-life [8, 30, 31] - APG777 Phase 2 induction exposures are designed to exceed EBGLYSS for potentially greater efficacy [35] - APG777 could substantially decrease annual injections for patients, potentially requiring only 2-4 injections compared to EBGLYSS (13-26) and DUPIXENT (26) [45, 46]