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Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

Shots:

  • The US FDA has granted ODD to CAL101 for the treatment of idiopathic pulmonary fibrosis (IPF)
  • CAL101 (IV, QM for 7mos.) is being investigated in a P-II (AURORA) trial against PBO in 150 IPF pts, with enrolment open in the sites across US, UK, EU, Turkey, & South Korea, evaluating lung function per forced vital capacity as 1EP
  • CAL101, a monoclonal antibody targeting the DAMP protein S100A4, aims to restore tissue homeostasis by inhibiting downstream pathways driving persistent & maladaptive scar formation in IPF

Ref: Calluna Pharma| Image: Calluna Pharma| Press Release

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