The Phase 1b/2 study, being conducted under a Clinical Trial Agreement between Mereo and the
Interim data from the first seven patients in this open-label study were presented at the 2020
Subsequent analysis of the elastin breakdown biomarker desmosine, has recently been completed. This demonstrated that all six patients with elevated desmosine levels at baseline (pre- treatment) showed a reduction in desmosine the within subject dose escalation period by week 8. A median reduction of 13.9% from baseline was observed at week 8, with a maximum reduction of 52%, supporting an effect of alvelestat to inhibit elastase in this population.
These changes in plasma desmosine, were supported by additional analysis of peripheral blood neutrophil elastase release in response to zymosan stimulation and taken from patients during the study. These showed suppression of elastase release, with a signal of increasing suppression over the dose escalation period. In some patients, there was complete suppression of elastase production, confirming the effect of alvelestat on the target mechanism of human neutrophil elastase inhibition and consistent with the desmosine changes.
'We have demonstrated that neutrophil elastase inhibition is well tolerated and shows a signal of stabilizing disease in patients with advanced BOS,' said Dr.
Additional biomarker analyses of the first seven patients are being conducted by
BOS is an inflammatory condition that affects the bronchioles, the smallest airways in the lungs. As the disease progresses, the bronchioles may become damaged and inflamed, leading to extensive scarring and blockage of the airways. Allogeneic HCT is associated with significant morbidity and mortality and BOS following a lung transplant is the leading cause of re-transplantation and mortality.
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