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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: 20 Aug 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

  • 11 Aug 2026 According to a Mereo Biopharma media release, company will lead the global Phase 3 study and regulatory interactions until study completion and will retain rest-of-world commercial rights for alvelestat.
  • 11 Aug 2026 According to Sentynl Therapeutics media release, Sentynl Therapeutics and Mereo BioPharma Group plc have entered into an option and license agreement for the U.S. commercial and global manufacturing rights to alvelestat. The agreement grants Sentynl global rights to manufacture alvelestat for AATD-LD and on option exercise, it provides funding for the alvelestat Phase 3 development program.
  • 11 Aug 2026 According to a Mereo Biopharma media release, the trial is planned to initiate in early 2027. Companies will collaborate to refine the Phase 3 design during short option period.

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