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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
Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation associated with exacerbations in asthma, with a robust
About this update from Apogee Therapeutics, Inc.
[{"type":"text","content":"Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation associated with exacerbations in asthma, with a robust maximal FeNO decrease from baseline of 53% APG808 demonstrated the potential for durable disease control in asthma with sustained FeNO decrease from baseline of 50% at 12 weeks APG808's optimized formulation and potential best-in-class pharmacokinetic (PK) profile, combined with robust and sustained FeNO suppression through 12 weeks, support the potential for transformative dosing every 2-months or longer, compared to the current biweekly standard of care APG808 was well tolerated with a favorable safety profile consistent with the anti-IL-4Rα class Phase 1b proof-of-concept data validates Apogee's approach to designing potentially best-in-class biologics and builds on Apogee's track record of execution SAN FRANCISCO and BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced positive interim data from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody, in patients with mild-to-moderate asthma. “Today’s results from the APG808 Phase 1b trial mark a significant milestone in its clinical development, as APG808 demonstrated a favorable safety profile and encouraging initial efficacy in patients with asthma,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “With its potential best-in-class PK profile, APG808 could substantially improve clinical outcomes for patients with asthma over the biweekly current standard of care and enable dosing as infrequently as every two months or longer. We believe today’s progress reinforces our ability to soundly execute and build a leading I&I company poised to redefine treatment paradigms for patients worldwide.” The Phase 1b double-blind, placebo-controlled, multiple-dose trial evaluated the safety and tolerability of APG808 in 22 adult patients with mild-to-moderate asthma. The trial also evaluated fractional exhaled nitric oxi...