9MW1911 / Mabwell (Shanghai) Biosci - LARVOL DELTA

Annualized Severe COPD Exacerbation Rate Reduced by Over 40%: Mabwell Announces Phase IIa Results for Innovative Anti-ST2 Antibody 9MW1911 (PRNewswire) - "At the recommended dose for the Phase IIb study (N=30), the annualized rate of moderate-to-severe COPD exacerbations was reduced by over 30% compared to the placebo group. Furthermore, the annualized rate of severe exacerbations was reduced by over 40% compared to the placebo group, and the proportion of patients experiencing severe exacerbations was significantly lower in the treatment group than in the placebo group (13.3% vs. 35%)."

P2a data • Chronic Obstructive Pulmonary Disease • Immunology

Safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of 9MW1911, an anti-ST2 monoclonal antibody: results from a first-in-human phase 1 study. (PubMed, Front Pharmacol) - P1 | "As 9MW1911 concentrations increased,the sustained elevation of sST2 in the higher dose levels (100mg-1200 mg) suggested that the target-mediated drug disposition (TMDD) elimination became saturated, leading to the observed linear PK profile. These data support the continued development of 9MW1911 for the therapeutic use in the relevant disease."

Clinical • First-in-human • Journal • P1 data • PK/PD data • IL33

First-in-human study of 9MW1911 (an anti-ST2 monoclonal antibody) in healthy volunteers (ERS 2025) - P1/2 | "9MW1911 was well-tolerated across various doses. The majority of adverse events (AEs) were of mild to moderate intensity. No dose-related AEs were observed."

Clinical • First-in-human • P1 data • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33

Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD). (clinicaltrials.gov) - P1/2 | N=80 | Active, not recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study to Evaluate the Pharmacokinetic Characteristics, Safety, Tolerability, and Preliminary Efficacy of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD). (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P1/2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Recruiting ➔ Completed

Trial completion • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Pulmonary Disease • Respiratory Diseases