Apogee Therapeutics, Inc. (NASDAQ:APGE) on Tuesday shared interim data from the Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma.
The data covers 19 adult patients with mild-to-moderate asthma. The trial also evaluated fractional exhaled nitric oxide (FeNO) suppression, a key biomarker of Type 2 inflammation. Zumilokibart demonstrated:
Robust and durable suppression of FeNO, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma, following a single dose.
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Data
Maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after a single dose.
Durable FeNO suppression through 16 weeks for all patients. Suppression of FeNO through 32 weeks for patients with available follow-up, supporting potential for 3- or 6-month dosing.
Positive trends were observed in forced expiratory volume in one second (FEV1) and across Type 2 biomarkers for all available data. FEV1 is a pharmacodynamic measure of lung function.
Zumilokibart was well-tolerated in patients with mild-to-moderate asthma. No conjunctivitis, injection site reactions, or anti-drug antibodies were observed.
Anticipated 2026 Key Milestones for zumilokibart
Phase 2 APEX Part A (52-week) maintenance data readout expected in the first quarter of 2026. Phase 2 APEX Part B (16-week) induction data readout – expected in the second quarter of 2026.
Initiation of Phase 3 trial – expected in the second half of 2026, enabling potential launch in 2029.
Phase 1b head-to-head clinical trial of APG279 (APG777+APG990) vs. DUPIXENT for moderate-to-severe AD readout remains on track – expected in the second half of 2026.
As of September 30, 2025, Apogee had total cash of $913 million with a cash runway into the second half of 2028.
APGE Price Action: Apogee Therapeutics shares were down 2.84% at $75.00 at the time of publication on Tuesday, according to Benzinga Pro data.
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