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A pivotal, single, global, Phase 3 study evaluating the 240 mg dose of alvelestat versus placebo in patients with alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD)

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Trial Profile

A pivotal, single, global, Phase 3 study evaluating the 240 mg dose of alvelestat versus placebo in patients with alpha-1-antitrypsin deficiency-associated lung disease (AATD-LD)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2026

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At a glance

  • Drugs Alvelestat (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Mereo BioPharma

Most Recent Events

  • 12 Jan 2026 According to a Mereo Biopharma media release, company continues to advance key activities to support the planned initiation of the global phase 3 pivotal study and remains in active discussions with potential partners for phase 3 development.
  • 12 Nov 2024 According to a Mereo Biopharma media release, following the FDA feedback on the detailed Phase 3 package, including the study protocol and the initial validation work on SGRQ in AATD, the Company continues to expect that alvelestat will be Phase 3 ready around the end of 2024. Company remains in discussions with several potential partners regarding the development and commercialization of alvelestat for AATD.
  • 13 Aug 2024 According to a Mereo Biopharma media release, At the end of Q2, Mereo submitted the initial validation work for SGRQ in AATD and the detailed Phase 3 package including the study protocol to the FDA.

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