A phase 2a, double-blind, randomised, placebo-controlled trial of the myeloperoxidase inhibitor, mitiperstat, in participants with COPD.
Dinesh Saralaya, M Nubli Mustapa, João Ferreira et al.
✦ AI-curated · Sources linked
In 30 seconds
This phase 2a, double-blind, randomised, placebo-controlled trial assessed mitiperstat in adults aged 40–80 years with moderate-to-severe COPD, high exacerbation risk, and ongoing dual or triple inhaled therapy. Among 381 participants treated for up to 24 weeks, 66.1% receiving mitiperstat and 65.1% receiving placebo experienced a COPDCompEx event. Mitiperstat did not improve time to the first such event (HR 1.07, 90% CI 0.87-1.32; p=0.599), time to exacerbation, lung function, symptoms, or disease impact. The authors concluded that risks outweighed benefits.
Key findings
- COPDCompEx events occurred in 66.1% of mitiperstat-treated participants and 65.1% of placebo-treated participants over 24 weeks.
- Time to first COPDCompEx event did not improve with mitiperstat versus placebo (HR 1.07, 90% CI 0.87-1.32; p=0.599).
- Mitiperstat did not improve time to first moderate-to-severe exacerbation, post-bronchodilator FEV1, respiratory symptoms, or disease impact.
- Adverse events were reported at similar proportions; pneumonia occurred in seven mitiperstat-treated participants and two placebo-treated participants.
Why it matters
The trial tested whether inhibiting myeloperoxidase could address neutrophilic inflammation in COPD, but found no benefit across exacerbation, lung-function, symptom, or disease-impact outcomes in this high-risk population. These results temper expectations for mitiperstat as a COPD treatment and underscore the importance of demonstrating clinical benefit alongside a plausible inflammatory mechanism.
What to keep in mind
Follow-up was limited to up to 24 weeks, so the trial provides limited evidence about longer-term outcomes.