Apogee Therapeutics (APGE) Study Result summary

Interim phase I-B asthma study results

• Single 720 mg dose of zumilokibart in mild to moderate asthma achieved or exceeded all trial objectives, showing robust and durable FeNO suppression comparable to standard-of-care agents like dupilumab.

• FeNO reduction was sustained through 16 weeks for all patients and up to 32 weeks for a subset, with maximum mean reduction of 45 ppb (60%), supporting potential for three- or six-month dosing intervals.

• Safety profile was favorable, with no serious or Grade 3/4 adverse events, no anti-drug antibodies, and no injection site reactions; most common TEAE was mild gastroesophageal reflux disease.

• Positive trends observed in FEV1 and Type 2 inflammatory biomarkers, with further data to be presented at upcoming conferences.

• Study population was enriched for Type 2 inflammation, with baseline FeNO ≥25 ppb and average eosinophil counts around 300, representative of future trial populations.

Mechanistic and clinical context

• IL-13 is a key cytokine in asthma pathogenesis, driving mucus hypersecretion, airway remodeling, and inflammation.

• Prior IL-13 antibody trials (e.g., lebrikizumab) showed efficacy in T2-high populations, highlighting importance of patient selection and adequate dosing.

• FeNO is a validated biomarker for Type 2 airway inflammation and correlates with asthma exacerbations; FDA recognizes FeNO as a potential surrogate endpoint.

• Durable FeNO suppression with zumilokibart aligns with exposures seen in atopic dermatitis studies and supports long-interval dosing.

• No conjunctivitis or injection site reactions observed in asthma patients, consistent with lower rates in non-dermatologic indications.

Key study objectives and design

• Phase 1b trial aimed to confirm safety and demonstrate activity of zumilokibart in asthma patients, focusing on FeNO reduction as a surrogate marker for Type 2 inflammation.

• Double-blind, placebo-controlled, single-dose regimen with 19 patients (3:1 active:placebo) meeting pre-specified criteria.

• Primary objectives included safety, maximum mean FeNO reduction, and sustained FeNO suppression to support infrequent dosing.

• Demographics and baseline characteristics were well-balanced between treatment and placebo groups.