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Apogee Therapeutics (APGE) Earnings Call Presentation
2025-07-04 07:41
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]
Apogee Therapeutics Announces Positive Interim Results from the Phase 1b Trial of APG808, its Novel Half-life Extended IL-4Rα Antibody, in Patients with Mild-to-Moderate Asthma
Globenewswire· 2025-05-12 10:00
Core Insights - APG808 shows significant potential in treating asthma, with a maximal FeNO decrease from baseline of 53% and sustained reduction of 50% at 12 weeks, indicating robust efficacy [1][4] - The drug's optimized formulation and promising pharmacokinetic profile suggest the possibility of extending dosing intervals to every two months or longer, which could redefine treatment standards for asthma patients [1][2][4] - The Phase 1b trial demonstrated a favorable safety profile, with no severe adverse events reported, reinforcing the drug's potential as a best-in-class therapy [2][4] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including asthma, atopic dermatitis, and chronic obstructive pulmonary disease [1][6] - The company aims to overcome limitations of existing therapies by targeting established mechanisms of action and optimizing antibody properties for improved efficacy and dosing [6] Trial Details - The Phase 1b trial was a double-blind, placebo-controlled study involving 22 adult patients with mild-to-moderate asthma, assessing the safety, tolerability, and efficacy of APG808 [2][4] - Key biomarkers evaluated included fractional exhaled nitric oxide concentration (FeNO), TARC, and pSTAT6, with results indicating significant suppression of Type 2 inflammation markers [4][5] Market Context - Asthma affects approximately 40 million adults and 12 million children in major markets, with prevalence rates ranging from 5% to 8%, highlighting the substantial need for effective treatments [3][5]