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A pivotal phase 3 study of PBI-4050 to treat mild-to-moderate idiopathic pulmonary fibrosis (IPF)

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Trial Profile

A pivotal phase 3 study of PBI-4050 to treat mild-to-moderate idiopathic pulmonary fibrosis (IPF)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2022

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At a glance

  • Drugs Fezagepras (Primary) ; Nintedanib
  • Indications Idiopathic pulmonary fibrosis
  • 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.
    • 28 Mar 2018 According to a ProMetic Life Sciences media release, the company has received FDA Investigational New Drug (IND) approval to commence this pivotal Phase 3 clinical trial.

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