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A Phase 2, Proof-of-concept, Multicentre, Double-blind, Randomised, Dose-ascending, Sequential Group, Placebo-controlled Study to Evaluate the Mechanistic Effect, Safety, and Tolerability of 12 Weeks Twice Daily Oral Administration of Alvelestat (MPH966) in Participants With Alpha-1 (PiZZ or Null) Antitrypsin Deficiency

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Trial Profile

A Phase 2, Proof-of-concept, Multicentre, Double-blind, Randomised, Dose-ascending, Sequential Group, Placebo-controlled Study to Evaluate the Mechanistic Effect, Safety, and Tolerability of 12 Weeks Twice Daily Oral Administration of Alvelestat (MPH966) in Participants With Alpha-1 (PiZZ or Null) Antitrypsin Deficiency

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Sep 2023

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At a glance

  • Drugs Alvelestat (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Biomarker; Pharmacodynamics; Proof of concept
  • Acronyms ASTRAEUS
  • Sponsors Mereo BioPharma
  • Most Recent Events

    • 24 May 2023 Results presented at the 119th International Conference of the American Thoracic Society
    • 24 May 2023 Results of an exploratory responder analysis assessing potential correlations between response of two blood biomarkers reflecting the pathogenic pathway of AATD-LD and a relevant clinical outcome presented at the 119th International Conference of the American Thoracic Society
    • 23 May 2023 According to a Mereo Biopharma media release, findings from this study have informed recent and ongoing discussions with both the FDA and EMA, and validate the proposed design for our planned Phase 3 trial, which will be the first registrational study in AATD-LD to use both a patient-reported outcomes approach and clinical outcome measure as independent primary endpoints.
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