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A multi-center pivotal, double-blind, placebo-controlled study with IPF patients on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo

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Trial Profile

A multi-center pivotal, double-blind, placebo-controlled study with IPF patients on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo

Status: Discontinued
Phase of Trial: Phase II/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.
    • 25 Sep 2017 According to a ProMetic Life Sciences media release, an Data and Safety Monitoring Board (DSMB) will conduct an interim 26-week analysis, and based on the safety and efficacy results, will recommend whether the study should continue into phase III stage and which dose of PBI-4050 should be continued.

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