APG333 / AbbVie - LARVOL DELTA

Phase 1 safety, pharmacokinetics, and sustained biomarker suppression with APG333, a novel half-life-extended anti-TSLP monoclonal antibody, in healthy adults (ERS 2026) - P1 | "In preclinical studies, APG333 demonstrated similar activity and potency compared with tezepelumab. APG333 was well tolerated across dose cohorts and showed a PK profile supporting every 3- and 6-month dosing. These results, together with the durable suppression of inflammatory biomarkers, support further clinical investigation with APG333, including in combination with other half-life-extended antibodies, for the treatment of diseases including asthma and COPD."

Biomarker • Clinical • First-in-human • P1 data • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Gastrointestinal Disorder • Immunology • Respiratory Diseases • IL5

Combination pipeline continues to advance across AD and respiratory conditions for APG279 and APG273 with potential for improved efficacy and dosing (GlobeNewswire) - "The Phase 1b head-to-head study evaluating APG279 (zumilokibart + APG990) versus DUPIXENT in atopic dermatitis is ongoing, with interim data expected in 2H 2026. APG273 (zumilokibart + APG333), a long-acting IL-13/TSLP combination, continues to represent a differentiated respiratory program supported by positive Phase 1 data for APG333, with additional plans to be announced in 2H 2026."

Clinical • P1 data • Atopic Dermatitis • Respiratory Diseases

A first-in-human study of APG333 in healthy participants (ANZCTR) - P1 | N=32 | Completed | Sponsor: Apogee Therapeutics, Inc. | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Interim data from APG333 Phase 1 healthy volunteer trial… (GlobeNewswire) - "APG333 demonstrated data supporting potential 3- and 6-month dosing based on a half-life of approximately 55 days across doses tested. Additionally, APG333 was well tolerated across all cohorts, with doses of up to 1,000 mg. Key biomarkers of eosinophils and IL-5 showed depth of suppression in line with TSLP analogs and durability out to 6 months."

P1 data • Chronic Obstructive Pulmonary Disease

Apogee Therapeutics Provides Pipeline Progress and Reports Second Quarter 2025 Financial Results (GlobeNewswire) - "A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the fourth quarter of 2025....Apogee expects to announce plans for its combination approach of APG777 + APG333 in respiratory conditions."

New trial • P1 data • Chronic Obstructive Pulmonary Disease

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Inhibits Central and Local Drivers of Obstructive Airway Disease (ATS 2025) - "Benchmark mAbs dupilumab (anti-IL-4Rα), lebrikizumab (anti-IL-13), and tezepelumab (anti-TSLP) were produced based on publicly available sequences. Consistent with TSLP and IL-13 having distinct roles in mediating obstructive airway disease pathology, administration of APG777+APG333 provided potent and broad inhibition of biomarkers of central inflammation and local airway response in primary human cells. Effects were greater and broader than those observed with benchmarks, suggesting that targeting orthogonal drivers of obstructive airway disease is a promising approach for the treatment of Th2-driven respiratory diseases. These data support the continued development of APG777+APG333 for Th2-driven inflammatory diseases."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CCL11 • CD4 • CRLF2 • IL13 • IL5 • IL6 • POSTN

A first-in-human study of APG333 in healthy participants (ANZCTR) - P1 | N=32 | Active, not recruiting | Sponsor: Apogee Therapeutics, Inc. | Not yet recruiting ➔ Active, not recruiting | Initiation date: Nov 2024

Enrollment closed • Trial initiation date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results (GlobeNewswire) - "Apogee plans to initiate a...Phase 2b trial in asthma in the second half of 2025 with data expected in 2026...A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025. Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD...Apogee is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025."

New P1 trial • New P2b trial • P1 data • P2b data • Asthma • Immunology • Respiratory Diseases

Preclinical and Pharmacokinetic Characterization of APG333: A Fully Human Monoclonal Antibody that Binds TSLP with High Affinity and Potently Inhibits Downstream Signaling (AAAAI-WAO 2025) - "An antibody based on the published sequence of tezepelumab was included as a control across in vitro and in vivo experiments characterizing APG333. The pharmacokinetic profile of APG333 in NHPs shows a reduced clearance and long half-life comparable with those seen with other half-life–extended mAbs. Conclusions In vitro potency and pharmacokinetic data support continued development of APG333 for the treatment of inflammatory diseases."

PK/PD data • Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CRLF2 • STAT5 • TSLP

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Improves Type 2 Inflammatory Suppression Compared to Single Agents (AAAAI-WAO 2025) - "Dupilumab and tezepelumab controls were produced based on publicly available sequences. Conclusions The combination of APG777+APG333 mediates greater suppression of Th2 immune response markers compared with both single-agent controls and benchmarks. These data support continued development of APG777+APG333 for Th2-driven inflammatory diseases."

Inflammation • CRLF2 • IL13 • TSLP

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG333, its Novel Half-Life Extended TSLP Antibody for the Treatment of Respiratory and Broader I&I Conditions (GlobeNewswire) - "Apogee Therapeutics, Inc...announced that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions....The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG333 and is expected to enroll approximately 32 healthy adults into 4 cohorts. Apogee expects interim data from the trial in the second half of 2025."

P1 data • Trial status • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A first-in-human study of APG333 in healthy participants (ANZCTR) - P1 | N=32 | Not yet recruiting | Sponsor: Apogee Therapeutics, Inc.

New P1 trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases