Idiopathic pulmonary fibrosis digest - 2021

Idiopathic pulmonary fibrosis digest - 2021

Liminal BioSciences to complete pharmacokinetic studies with Fezagepras before initiating Phase 2 study

Fezagepras (FFAR1/ PPAR alpha modulator) – Liminal BioSciences

  • Liminal BioSciences stopped its plans to move fezagepras into a Phase 2 clinical study in idiopathic pulmonary fibrosis based on interim pharmacokinetic results from the ongoing fezagepras multiple ascending dose (MAD) study
  • Trial details: NCT04695041; Phase 1 in healthy volunteers; N= 72; Fezagepras 1200 mg, 1600 mg, 2000 mg, 2400 mg TID for 14 days; Primary outcomes: Safety and tolerability; PCD: Jun’21; Recruiting; Location: UK
  • They will evaluate the impact of the PK data profile observed in the ongoing MAD study
  • They will analyze the complete PK data set from the Phase 1 study to determine other potential indication(s) (For full story click here)

Luminal BioSciences stopped its Phase 2 plans for Fezagepras

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CI Scientists Commentary:

  • The decision to halt comes shortly after the company announced plans to launch a Phase 2 trial in early 2022
  • Although Luminal said that there were no DLTs and other safety concerns with fezagepras, the reason for the halt is not known
  • There is a possibility that the complete PK data set may help Luminal choose the optimal dose, the frequency for the anticipated Phase 2 trials for fezagepras

– Dr. Kowndinya, CI Scientists

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