Mabwell Reports Significant Reduction in COPD Exacerbations with 9MW1911 Antibody in Phase IIa Study

Mabwell's Phase IIa Trial Results: A New Hope for COPD Patients

In a groundbreaking development, Mabwell (688062.SH), a leading innovation-focused biopharmaceutical company, has announced remarkable results from their Phase IIa clinical trial for 9MW1911, an innovative anti-ST2 monoclonal antibody designed for treating moderate-to-severe chronic obstructive pulmonary disease (COPD). This study, known as 9MW1911-C03, emphasizes Mabwell's commitment to enhancing therapeutic options in the healthcare landscape.

Study Overview

The Phase IIa trial was a randomized, double-blind, placebo-controlled study, which involved 80 patients who had a history of smoking and were diagnosed with moderate-to-severe COPD. Participants were administered intravenous infusions of 9MW1911 in various dosages (100mg, 300mg, 600mg, 900mg) or placebo every four weeks. The primary objectives were to evaluate the safety, tolerability, and pharmacoknetic properties of the drug, along with initial efficacy assessments.

Safety and Tolerability Findings

Results demonstrated that 9MW1911 was well tolerated across all dosage groups, with an overall adverse event (AE) incidence of 70%, compared to 85% in the placebo group. Importantly, immunogenicity tests returned negative results across all participants, indicating that there were no adverse immune responses provoked by the treatment. No new safety signals emerged, reinforcing confidence in the therapeutic potential of the drug.

Efficacy Outcomes

The efficacy data sourced from the trial were equally promising. The annualized rate of moderate-to-severe COPD exacerbations revealed a dose-dependent decrease in exacerbations. Specifically, at the recommended dosage for the upcoming Phase IIb study, the rate of these exacerbations showcased a reduction of over 30% in comparison to placebo. The rate of severe exacerbations saw an even more significant drop, exceeding 40%. Notably, only 13.3% of patients receiving 9MW1911 experienced severe exacerbations compared to 35% in the placebo cohort.

Path Forward

Following the encouraging outcomes from the Phase IIa trial, Mabwell is proceeding with plans for a Phase IIb study that includes a larger cohort of COPD patients. Dosing for the first patient commenced in July 2025, with expectations for interim analysis upon collecting data from at least 120 subjects. A Phase III trial is anticipated to follow, shaped by the success of these initial stages, potentially launching by the end of 2026.

The trial application for Phase IIa has recently been accepted by the U.S. Food and Drug Administration (FDA), symbolizing a pivotal step in Mabwell's journey toward bringing this innovative treatment option to market.

About Mabwell

Mabwell is an innovation-driven biopharmaceutical entity committed to developing advanced therapies across the pharmaceutical value chain, specifically targeting oncology and age-related diseases. With a vision of transforming innovative ideas into tangible health benefits, the company's motto, "Explore Life, Benefit Health,” resonates throughout its mission.

For more information on Mabwell and its range of products, visit Mabwell's website.

Conclusion

The results from Mabwell’s Phase IIa study hold significant promise for the future treatment of COPD, a condition affecting millions worldwide. As the company moves forward with subsequent trials, patients and healthcare providers alike remain hopeful for breakthrough advancements in COPD management.