Mereo BioPharma has presented data from the phase 2 “ASTRAEUS” trial of alvelestat in alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), as well as post hoc analyses demonstrating the association between biomarker reductions and improvements in St. George’s Respiratory Questionnaire (SGRQ) score in alvelestat-treated subjects at the 2023 American Thoracic Society (ATS) International Conference.
“We are very pleased to have these data presented to the scientific community for the first time at ATS2023. These findings have informed our recent and ongoing discussions with both the FDA [US Food and Drug Administration] and EMA [European Medicines Agency], and validate the proposed design for our planned phase 3 trial, which we believe will be the first registrational study in AATD-LD to use both a PRO [patient-reported outcome] approach and an objective clinical outcome measure as independent primary endpoints,” said Denise Scots-Knight, PhD, CEO of Mereo BioPharma.
“We are excited by the potential of alvelestat to become the first-in-class oral neutrophil elastase inhibitor for the treatment of AATD-LD and look forward to continued collaboration with the regulatory authorities, scientific and patient communities as we further refine our development plans ahead of the pivotal study. We look forward to sharing further updates on the progress of the alvelestat program, including the results of the investigator-led phase 2 ATALANTA study evaluating alvelestat in combination with augmentation therapy, which is expected to read out in Q3 2023.”
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Treatment with high-dose alvelestat led to significant and consistent reductions in all the 3 biomarkers related to AATD-LD disease activity—blood neutrophil elastase, Aα-val360, and desmosine.
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Moreover, findings from post hoc analyses revealed an association between biomarker reductions and degree of improvement in the SGRQ-activity domain score of patients treated with alvelestat.
Mereo is now preparing a single pivotal phase 3 study evaluating high-dose alvelestat. The planned study will have 2 primary endpoints: change from baseline in the SGRQ-Activity Domain score and lung density measured by computed tomography scan, as guided by the FDA and EMA, respectively.
“We are grateful that the alvelestat data presented this week has been received with such interest and enthusiasm by the respiratory community,” said Jackie Parkin, PhD, SVP and therapeutic head at Mereo BioPharma.
“The attendance at our poster session yesterday and active engagement with thought leaders during and outside of Professor Stockley’s oral presentation earlier today are a clear reflection of the excitement toward alvelestat and its potential to improve the lives of patients with AATD-LD. I would like to thank Professor Stockley and the other ASTRAEUS investigators and their staff for their ongoing commitment to advancing alvelestat, as well as the patients, their caregivers and families who participated in the study, and to the Alpha-1 Project for their contribution to funding this work. We look forward to further collaboration as we advance toward the planned phase 3 study and remain firmly committed to our mission.”
Reference
Phase 2 data from “ASTRAEUS” trial of Mereo BioPharma’s alvelestat in alpha-1 antitrypsin deficiency-associated lung disease presented at the 2023 American Thoracic Society International Conference. News release. Mereo BioPharma Group; May 23, 2023.
