Apogee Therapeutics (NASDAQ:APGE) presented interim Phase 1b data for its IL-13 antibody zumilokibart (APG777) in mild to moderate asthma, highlighting what the company described as a robust and durable reduction in fractional exhaled nitric oxide (FeNO) following a single dose. Executives positioned the readout as the first of four key clinical catalysts expected in 2026 and said the results further support a strategy of developing “a pipeline-in-a-product” spanning atopic dermatitis, asthma, and other Type 2 inflammatory diseases.
Interim Phase 1b asthma results: FeNO reduction and durability
Chief Medical Officer Carl Dambkowski said the trial achieved or exceeded its objectives across safety, magnitude of biomarker response, and durability. In the double-blind, placebo-controlled study, 19 adult patients with mild to moderate asthma and baseline FeNO of at least 25 parts per billion (ppb) were randomized 3:1 to receive a single 720 mg dose of zumilokibart or placebo on day one. The FeNO entry criterion was intended to enrich the study for patients with Type 2 inflammation.
Management compared the magnitude of FeNO reduction to standard-of-care treatments such as dupilumab, noting that the week 12 FeNO change was “in line with effective and approved agents such as DUPIXENT and TEZSPIRE,” which are dosed more frequently over a similar time period.
Safety observations and additional signals
Dambkowski said the single 720 mg dose was well tolerated, describing the safety profile as consistent with expectations for IL-13-targeting therapies and with prior zumilokibart studies. The only treatment-emergent adverse event reported in more than one patient was gastroesophageal reflux disease, with two grade 1 cases. The company reported no grade 3 or higher treatment-emergent adverse events and no serious adverse events. Apogee also said there were no observed cases of conjunctivitis or injection site reactions in this asthma study.
Beyond FeNO, Dambkowski said Apogee is observing positive trends for FEV1 and Type 2 inflammatory biomarkers, but he and CEO Michael Henderson said the company will reserve quantitative details for a future medical conference presentation.
Scientific context for IL-13 inhibition in asthma
Dr. Mario Castro, a University of Kansas Medical Center professor and pulmonary specialist, provided context on IL-13 biology in asthma and reviewed prior clinical work with IL-13 inhibition. Castro described IL-13 as a key mediator of Type 2 asthma, linking it to mucus hypersecretion, airway hyperactivity, and eosinophilic inflammation, as well as airway remodeling features such as epithelial thickening, subepithelial fibrosis, goblet cell hyperplasia, and increased smooth muscle mass.
Castro also referenced previous lebrikizumab studies, saying they did not demonstrate significant benefit in initial readouts, but post-hoc analyses suggested efficacy in more selectively defined high Type 2 populations. He highlighted that selecting patients based on higher biomarkers—such as FeNO of 50 ppb or more or blood eosinophils of 300 or more—was associated with reduced exacerbations in those analyses.
On Apogee’s interim data, Castro said the Phase 1 study showed “significant and durable” suppression of FeNO after a single dose and noted that seeing FEV1 improvements as an early signal in a Phase 1 setting can be encouraging, as lung function changes are often more clearly demonstrated later in development.
Development plans and 2026 catalysts
CEO Michael Henderson described the interim asthma data as the first of four important readouts for 2026. He said Apogee expects to report 52-week maintenance data from Part A of the Phase 2 APEX study in moderate to severe atopic dermatitis in the first quarter, followed by Part B dose-optimization data in the second quarter. Henderson said Part B enrolled 347 patients, exceeding the company’s target and enabling an accelerated timeline that could support initiation of Phase 3 studies this year.
Henderson said Apogee believes it is working toward a potential best-in-class profile for zumilokibart in atopic dermatitis, with a planned potential 2029 launch and dosing every three or six months. He also pointed to earlier APEX Part A data in atopic dermatitis that included improvements in comorbid conditions among patients with asthma or sinusitis, measured by ACQ-5 and SNOT-22, respectively.
In asthma, Henderson said the company is evaluating the “most expeditious path” for the planned ASPIRE trial but did not specify whether it will be Phase 2 or pivotal, stating that additional details will be provided later in the year.
Commercial positioning: dual labeling and longer dosing intervals
In the Q&A, Chief Commercial Officer Jeff Hartness argued that a therapy with both atopic dermatitis and asthma indications could be commercially meaningful, pointing to what he described as the importance of comorbidity between the two conditions. Hartness said DUPIXENT is currently the biologic asthma market leader despite every-two-week dosing and being “fourth to market,” which he attributed in part to its presence in both asthma and atopic dermatitis. Hartness also said payer access discussions in atopic dermatitis could be strengthened by an asthma “line extension,” given that the two indications are, in his view, DUPIXENT’s largest by volume and revenue.
Apogee executives also emphasized dosing frequency as a differentiator. Hartness said adherence to DUPIXENT in asthma in the first year is “in the 55% range” and argued that longer dosing intervals could improve adherence and outcomes. Management repeatedly suggested the asthma FeNO durability supports exploring every three- or six-month dosing in future studies.
Apogee also discussed combination approaches, including APG279 (a fixed-dose combination targeting IL-13 and OX40L) enrolling in atopic dermatitis head-to-head versus DUPIXENT, with a readout expected in the second half of 2026, and APG273 (a fixed-dose combination targeting IL-13 and TSLP), with more respiratory details expected later in 2026. Dambkowski said combinations may be especially relevant for less Type 2-enriched populations, and he said Apogee views a 40% to 50% reduction in annualized exacerbation rates as a meaningful bar in patients with eosinophils below 150 in that context.
About Apogee Therapeutics (NASDAQ:APGE)
Apogee Therapeutics, Inc is a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics that selectively target the nuclear receptor RORγt, a master regulator of T cell-driven inflammatory pathways. By modulating RORγt activity, Apogee aims to offer an oral treatment option for patients with autoimmune and inflammatory skin disorders.
The company’s lead candidate, APG-157, is an oral RORγt inverse agonist currently undergoing early-stage clinical evaluation for moderate to severe plaque psoriasis.
