sunakiment (AZD8630) / AstraZeneca, Amgen - LARVOL DELTA

Lessons learned from clinical trials of thymic stromal lymphopoietin (TSLP) inhibition. (PubMed, J Allergy Clin Immunol) - "Tezepelumab is currently the only approved anti-TSLP therapy. Other TSLP-targeting agents, including ecleralimab, SHR-1905, bosakitug, verekitug, sunakiment, TAVO101, ocankitug, HBM9378, MG-ZG122, GB-0895, and solrikitug, are in clinical development."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • IL13 • IL5 • TSLP

Sunakiment (AMG 104/AZD8630) (PRNewswire) - "In collaboration with AstraZeneca, the Company is planning a Phase 3 development program in asthma."

New P3 trial • Asthma • Immunology

AZD8630/AMG 104, an inhaled Anti-TSLP antibody fragment, for moderate-to-severe asthma: a phase 1 randomized controlled trial. (PubMed, J Allergy Clin Immunol) - "AZD8630/AMG 104 was well tolerated, with pharmacokinetics suitable for once-daily dosing. Results demonstrate proof-of-mechanism: clinically meaningful reductions in FeNO levels and evidence of target engagement. Further development of AZD8630/AMG 104 in adults with moderate-to-severe asthma is warranted. CLINICAL IMPLICATION (30/30): AZD8630/AMG 104, an inhaled anti-TSLP biologic, was well tolerated, suitable for once-daily dosing, and demonstrated clinically meaningful, significant FeNO reduction supporting pharmacodynamic activity and justifying progression to dose response optimization. CAPSULE SUMMARY (34/35): In this first-in-human Phase 1 study, AZD8630/AMG 104, a novel inhaled anti-TSLP antibody fragment, was well tolerated. Results demonstrated proof-of-mechanism as shown by clinically meaningful reductions in FeNO levels in participants with moderate-to-severe asthma."

First-in-human • Journal • P1 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AZD8630, Administered Once Daily via Inhalation, for 2 Weeks, in Adults With Asthma on Medium-to-high Dose Inhaled Corticosteroids and Long-acting Beta-agonists (ATS 2026) - No abstract available

Clinical • PK/PD data • Asthma • Immunology • Respiratory Diseases

Levante: A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations (clinicaltrials.gov) - P2 | N=537 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

D6830C00003: A trial to learn how safe AZD8630 is and how well it works in adults with uncontrolled asthma. (clinicaltrialsregister.eu) - P1/2 | N=110 | Completed | Sponsor: AstraZeneca AB | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Levante: A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations (clinicaltrials.gov) - P2 | N=534 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

APkITA: A Study of Inhaled AZD8630 in Adolescents With Asthma (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed | N=18 ➔ 10 | Trial completion date: Feb 2026 ➔ Sep 2025 | Trial primary completion date: Feb 2026 ➔ Sep 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: AstraZeneca | Phase classification: P1/2 ➔ P1

Phase classification • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

APkITA: A Study of Inhaled AZD8630 in Adolescents With Asthma (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: AstraZeneca

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

A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "Blinatumomab: A Phase 2 study of blinatumomab in autoimmune disease was initiated in patients with systemic lupus erythematosus (SLE)....Inebilizumab: A Phase 2 study of inebilizumab in autoimmune disease was initiated in patients with SLE. AMG 104 (AZD8630): A Phase 2 study is enrolling patients with asthma.'"

New P2 trial • Trial status • Asthma • Systemic Lupus Erythematosus

A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: AstraZeneca

New P1/2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants. (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

Levante: A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations (clinicaltrials.gov) - P2 | N=516 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Trial primary completion date: May 2025 ➔ Mar 2026

Enrollment open • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Proof of Mechanism for an inhaled anti-TSLP fragment antibody, AZD8630/AMG104, in a phase 1 study in healthy adults and asthma patients (ERS 2024) - P1 | "Results demonstrate proof of mechanism for AZD8630/AMG104 and support further development as a potential treatment for asthma. Future work will confirm TE and broaden understanding of PD responses in the airway of asthmatics."

Clinical • P1 data • Asthma • Immunology • Respiratory Diseases • IL5 • TSLP

Pharmacokinetics of AZD8630/AMG 104 inhaled anti-TSLP in healthy adults and asthma patients (ERS 2024) - P1 | "AZD8630/AMG 104 displayed dose proportional PK characteristics in the dose range studied and a half-life suitable for once-daily dosing. Together with low rates of immunogenicity following 4-weeks of dosing this data supports the ongoing development of AZD8630/AMG 104 as a first-in-class inhaled biologic treatment option for asthma patients."

Clinical • PK/PD data • Asthma • Immunology • Respiratory Diseases • TSLP

A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants. (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants. (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

Levante: A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations (clinicaltrials.gov) - P2 | N=516 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Phase 1 Safety and Efficacy of AZD8630/AMG 104 Inhaled Anti-TSLP in Healthy Volunteers and Patients With Asthma on Medium-High Dose Inhaled Corticosteroid (ICS) and Long-Acting Beta-agonist (LABA) With Elevated Baseline Fractional Exhaled Nitric Oxide (FeNO) (ATS 2024) - P1 | "AZD8630 was safe and well tolerated in healthy volunteers and patients with moderate to severe asthma in the doses studied up to 28 days. ADA incidence was low overall in this study. No TEAEs associated with ADA were reported."

Clinical • Late-breaking abstract • P1 data • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

AMGEN HIGHLIGHTS NEW COPD, ASTHMA AND VASCULITIS RESEARCH AT ATS 2024 (PRNewswire) - "Amgen...today announced the presentation of new respiratory data at the American Thoracic Society (ATS) 2024 International Conference taking place May 12-22 in San Diego....'We look forward to presenting encouraging data from our Phase 2a COURSE trial in COPD with Tezspire and our Phase 1 investigational study of asthma with AMG104/AZD8630, an inhaled anti-TSLP therapy,'...Other research highlights include late-breaking data from the Phase 1 study of AMG104/AZD8630, an investigational inhaled anti-TSLP therapy being evaluated in patients with poorly controlled asthma, as well as a post-hoc analysis from the Phase 3 ADVOCATE trial."

Clinical data • Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease

A Study to Investigate the Safety, Tolerability and Effects of AZD8630 in Healthy Subjects and Subjects With Asthma on Inhaled Corticosteroids and Long-acting Beta-agonists (clinicaltrials.gov) - P1 | N=170 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases