Mereo's Alvelestat Shows Encouraging Biomarker Data In Bronchiolitis Obliterans Syndrome

Mereo BioPharma Group plc MREO has announced data from an interim analysis of an investigator-initiated study of alvelestat, in patients with Bronchiolitis Obliterans Syndrome (BOS), following hematopoietic stem cell transplantation (HCT).
The Phase 1b/2 study, being conducted under a Clinical Trial Agreement between Mereo and the National Cancer Institute, plans to recruit a total of 30 patients.
The primary endpoints of the study are to define the safety and the optimal biological dose based on neutrophil elastase inhibition measured using biomarkers at eight weeks and clinical efficacy at six months.
Interim data from the first seven patients were presented at the 2020 American Society of Hematology Annual Meeting in December 2020.
Six patients had stable disease, while one patient had progression in the setting of pneumonia.
Subsequent analysis demonstrated that all six patients with elevated desmosine levels at baseline (pre-treatment) showed a reduction in desmosine within-subject dose-escalation period by week eight.
A median reduction of 13.9% from baseline was observed at week eight, with a maximum reduction of 52%.
Additional biomarker analyses of the first seven patients are being conducted and expected to be presented at ASH 2021.
BOS is an inflammatory condition that affects the bronchioles, the smallest airways in the lungs.
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