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A Pivotal, Placebo-Controlled, Randomised, Phase III Clinical Trial of PBI-4050 in Patients with Alstrom's Syndrome

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Trial Profile

A Pivotal, Placebo-Controlled, Randomised, Phase III Clinical Trial of PBI-4050 in Patients with Alstrom's Syndrome

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2022

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At a glance

  • Drugs Fezagepras (Primary)
  • Indications Alstrom's Syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Liminal BioSciences

    • Most Recent Events

    • 21 Jul 2022 According to Liminal BioSciences media release, the company has discontinued development of fezagepras based on results from the Phase 1a single ascending dose ("SAD") clinical trial, which indicated fezagepras was significantly inferior compared to Sodium Phenylbutyrate as a nitrogen scavenger. The recommendation to stop the development program for fezagepras was not based on safety concerns.
    • 21 Jul 2022 Status changed from planning to discontinued, according to a Liminal BioSciences media release.
    • 09 Sep 2019 According to a ProMetic BioSciences media release, PBI-4050, is expected to enter this trial after approval by the FDA and EMA.

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