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Apogee Therapeutics (APGE) investor relations material
Apogee Therapeutics Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
Interim results and efficacy
Interim phase 1b results showed robust, rapid, and durable FeNO suppression, with a 60% reduction (45 ppb) sustained for at least 16 weeks after a single 720 mg dose, and up to 32 weeks in some patients.
FeNO suppression was competitive with or exceeded standard-of-care biologics, including DUPIXENT and TEZSPIRE, which require more frequent dosing.
Positive trends were observed in FEV1 and Type 2 inflammatory biomarkers, with further data to be presented at upcoming conferences.
The study population was enriched for Type 2 inflammation, with most patients having eosinophil counts ≥150, aligning with future trial plans.
Safety and tolerability
The safety profile was favorable, with no serious or drug-related adverse events, no Grade 3/4 TEAEs, and no anti-drug antibodies detected.
Only mild, grade 1 gastroesophageal reflux (GERD) was reported in more than one patient; no cases of conjunctivitis or injection site reactions.
Safety profile consistent with other IL-13 targeting therapies in asthma.
Demographics and baseline characteristics were well-balanced between treatment and placebo groups.
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