Larimar under pressure as FDA puts clinical hold on CTI-1601 program

May 26, 2021 1:25 AM ETLarimar Therapeutics, Inc. (LRMR)LRMRBy: Mamta Mayani, SA News Editor
  • Larimar Therapeutics (NASDAQ:LRMR) slumps 45% in after-hours trading after announcing that the FDA has placed a clinical hold on the CTI-1601 clinical program and that the company will not be closing its previous private placement financing.
  • The clinical hold follows the mortalities which occurred at the highest dose levels in an ongoing 180-day non-human primate (NHP) toxicology study, previously reported in Phase 1 multiple ascending dose trial evaluating CTI-1601 as a treatment for Friedreich’s ataxia (FA).
  • CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with FA who are unable to produce enough of this essential protein.
  • The FDA stated it needs a full study report from the ongoing NHP study and Larimar may not initiate additional clinical trials until the reports have been submitted or further notified by the Agency.
  • Larimar launched $95M private placement on May 21, to support the clinical development of CTI-1601.

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