Apogee Therapeutics reports ‘positive’ results from Phase 1b zumilokibart trial

Apogee Therapeutics (APGE) announced positive interim data from the Phase 1b trial of zumilokibart in patients with mild-to-moderate asthma and highlighted upcoming 2026 milestones. The company recently received approval for the International Non-proprietary Name of zumilokibart for APG777. Zumilokibart is a novel, half-life extended anti-IL-13 antibody. In the trial, zumilokibart demonstrated: Favorable safety profile; zumilokibart was well-tolerated in patients with mild-to-moderate asthma. The only treatment-emergent adverse event observed in more than one patient was gastroesophageal reflux disease. There were no Grade 3 or higher TEAEs or serious adverse events. No conjunctivitis, injection site reactions, or anti-drug antibodies were observed. 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. Maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after 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 observed in forced expiratory volume in one second and across Type 2 biomarkers for all available data. FEV1 is a pharmacodynamic measure of lung function. Further data from the study will be shared at upcoming medical conferences.