Update from Larimar Therapeutics

  • Food and Drug Administration (FDA) removed partial clinical hold following review of Phase 2 dose exploration study data
  • Ongoing open label extension (OLE) study initially evaluating 25 mg; Larimar plans to dose escalate to 50 mg following further characterization of frataxin pharmacodynamics (PD) at the 25 mg dose
  • Interim data from OLE study remains on track for Q4 2024
  • Biologics License Application (BLA) submission targeted for the second half of 2025