Mabwell received thumbs up from the IND for its clinical study based on COPD

Announcement

Mabwell, a leading innovation enthusiast biopharmaceutical company with a fully unified industry chain, has declared that it has received clearance from the U.S. Food and Drug Administration (FDA) for its own established anti-ST2 monoclonal antibody to begin with a Phase 2a clinical study in patients suffering from moderate to extreme chronic obstructive pulmonary disease (COPD).

Presenting as a first-ever domestic anti-ST2 monoclonal antibody candidate, it has made its place in clinical trials. The clinical trials for 9MW1911 attested to the ST2 receptor holding a high affinity to stop the IL-33/ST2 signalling pathway. Till now, it has completed the Phase 2a study (N=80) in moderate to extreme COPD patients in China.

Results

The results showed that 9MW1911 was tolerable and safe throughout all dose cohorts in comparison to placebo tested (N=20), with a matched negative event scenario presenting 70% vs. 85%. Alongside the Immunogenicity was seen in a bad light for every subjects and new safety risks were absent. Based on pharmacokinetics, the drug exposure elevated as doses escalation. The exposure-response model can be developed to specify the dose impact connection at first place, delivering a basis for incidental dose selection.

The pharmacokinetics results advise that the medicine's exposure rate accelerated with the escalating doses. Whereas the efficacy data unveiled that the yearly exacerbation rate of COPD illustrates a reduction in dose dependency in the treatment arms. As per the suggested Phase 2b dose (RP2D, N=30), the yearly rate of moderate to extreme COPD exacerbations was mitigated by above 30% in comparison to the placebo group. Further, the yearly calculation of extreme exacerbations at the RP2D came down by 40%.

The number of patients suffering extreme exacerbations was noted to be less than that of the placebo group, showing a difference as 13.3% vs. 35%. Now, the Phase 2b clinical trial assessed 9MW1911 in a vast COPD population and has already completed its dosing event in July 2025, with an interim analysis intended after receiving data from 120 patients.

On learning the assessment of Phase 2 outcomes, Mabwell is now preparing its Phase 3 clinical study launch by the 2026 year-end to address the drug’s efficacy, immunogenicity and safety. This IND clearance will help the company to take the lead in the ongoing trial and give confidence to start with another trial in favor of COPD patients.