COPD experimental therapy moves into new phase after positive results
Phase 2a data show fewer severe exacerbations and a favorable safety profile
Mabwell’s experimental therapy 9MW1911 may reduce the frequency of moderate to severe exacerbations in people with chronic obstructive pulmonary disease (COPD), according to data from a completed Phase 2a clinical trial.
The results were announced in a press release from Mabwell. The company is now conducting a Phase 2b trial to further evaluate the safety and efficacy of the recommended 9MW1911 dose identified in the China-based Phase 2a trial (NCT06175351).
Mabwell reported that the first COPD patients in the Phase 2b trial were dosed over the summer, and an interim analysis is planned once data from at least 120 participants are available. If results are positive, the company aims to begin Phase 3 testing before the end of 2026.
Understanding COPD and why exacerbations matter
COPD is marked by chronic inflammation in the lungs that blocks airflow, leading to symptoms such as shortness of breath, wheezing, and persistent cough.
Exacerbations, or flare-ups, are common, with more than 70% of patients experiencing at least one within three years of diagnosis. These episodes can last several days, accelerate lung-function decline, reduce physical functioning and quality of life, and may require medical treatment or hospitalization.
9MW1911, administered by intravenous infusions, is an antibody-based therapy designed to block the activity of ST2, a receptor involved in responses to inflammation-driving signaling molecules. By blocking this pathway, the therapy is expected to reduce lung inflammation.
A previous China-based Phase 1 clinical trial (NCT05803902) evaluated the safety of 9MW1911 in 48 healthy volunteers. Results showed the therapy was generally safe and well tolerated, with no treatment-related serious adverse events.
The completed Phase 2a trial enrolled 80 people with moderate-to-severe COPD who previously smoked. Participants were randomly assigned to receive one of four doses of 9MW1911 (100, 300, 600, or 900 mg) or a placebo, administered once every four weeks for up to eight months.
What the Phase 2a trial set out to measure
The study’s main goals were to assess the safety and pharmacokinetic characteristics of 9MW1911, and results were overall positive. According to Mabwell, adverse events occurred at similar rates in people given 9MW1911 or placebo (70% vs. 85%).
None of the participants experienced immune reactions to the therapy, and no new safety risks were identified. Data showed dose-dependent drug exposure, which helped researchers identify the optimal dose for Phase 2b testing.
An exploratory goal of the Phase 2a trial was to evaluate whether 9MW1911 could reduce COPD exacerbations.
The 30 participants who received the recommended Phase 2b dose experienced a more than 30% reduction in annualized rates of moderate-to-severe COPD exacerbations and a more than 40% reduction in severe exacerbations compared with placebo.
Patients receiving the optimal dose were also significantly less likely to experience severe exacerbations than those on placebo (13.3% vs. 35%).
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