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GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis

GRI
  • GRI Bio, Inc. announced that the U.S. FDA granted Orphan Drug Designation to GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF).
  • The designation provides a potential pathway to seven years of U.S. market exclusivity upon approval.
  • Additional benefits include potential tax credits for clinical development expenses, waivers of certain FDA application fees, & enhanced regulatory engagement.
  • GRI-0621 is an oral, once-daily RARβ/γ-selective agonist designed to modulate pathways involved in inflammation & fibrosis.
  • The drug's Phase 2a trial (NCT06331624) in 35 IPF patients met all primary, secondary, & exploratory endpoints.
  • Approximately 80% of the trial participants were on background standard-of-care antifibrotics.
  • IPF is a progressive, irreversible lung disease affecting fewer than 200,000 people in the U.S., creating a significant unmet medical need.
  • GRI Bio's CEO Marc Hertz stated the designation validates the development strategy & strengthens the company's ability to advance the program efficiently.
  • The company continues to execute its broader strategy of developing therapies for immune dysregulation & fibrosis, including a pipeline of dNKT agonists.
  • Forward-looking statements in the release include risks regarding financing, regulatory approval, clinical trial outcomes, & intellectual property protection.