At the 2025 European Respiratory Society (ERS) International Congress takig place in Amsterdam, the Netherlands, from 27 September to 1 October 2025, Apogee Therapeutics has presented clinical data for APG808, the company’s novel anti-interleukin (IL)-4Rα monoclonal antibody inhibitor targeting mild-to-moderate asthma. The findings were from the Phase Ib (ACTRN12624000238572) multiple-dose study evaluating APG808 and its effect on type 2 (T2) inflammatory biomarkers in mild-to-moderate asthma patients. With the same mechanism of action as Sanofi/Regeneron’s Dupixent (dupilumab), Apogee is positioning its asset as an appropriate biological option for mild-to-moderately asthmatic patients, as Dupixent is currently only approved for those with severe disease.
With a relatively long half-life, as shown through pre-clinical studies presented at the American Thoracic Society International Conference (ATS) 2024, APG808 could ultimately be differentiated from comparable therapies in this drug class by providing a favourable dosing schedule. The currently proposed APG808 administration of 600mg every four weeks is a strong point of distinction from other therapies in this drug class, such as Dupixent with its maintenance dosing schedule of administration every two weeks (ATS 2024 abstracts A5402 and A5385).
The clinical study evaluated APG808 through a multiple-dose, randomised, double-blind cohort that included 22 participants with mild-to-moderate asthma and baseline elevated fractional exhaled nitric oxide (FeNO; ≥25ppb), a marker of airway inflammation. Participants were randomised 3:1 to receive subcutaneous APG808 600mg or placebo on Days 1 and 29. Throughout the 12-week study, FeNO and rates of adverse events were assessed at multiple timepoints, in addition to the pharmacodynamic biomarkers of phosphorylated signal transducer and activator of transcription 6 (pSTAT6), and thymus and activation-regulated chemokine (TARC).
APG808 resulted in a rapid and durable decrease from baseline in FeNO and pSTAT6 measurements throughout the 12 weeks. Similar findings were not observed in the placebo-controlled group. Larger declines in TARC from baseline were also noted in the APG808-treated patients compared to the control group. APG808 was well-tolerated in participants with asthma. Similar treatment-emergent adverse events were seen in both the APG808-treated and control patient cohorts. There were no severe adverse events.
In this Phase Ib study of patients with mild-to-moderate asthma, APG808 demonstrated a favourable safety profile consistent with the anti-IL-4Rα class. The optimised pharmacokinetic profile, in addition to the durable suppression of FeNO, a T2 biomarker associated with asthma exacerbations, supports continued clinical development of APG808. Of the 17 biologics currently in late-stage development to treat asthma, none aimed to treat patients with mild-to-moderate disease severity. If APG808 advances to market, it will be well-positioned to address the unmet need for a biologic therapy developed to treat this underserved patient population. Â
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