Larimar Therapeutics, Inc. (LRMR) Tuesday announced that FDA has removed the partial clinical hold placed on its nomlabofusp or CTI-1601, a clinical program targeting treatment of patients with Friedreich's Ataxia.
Nomlabofusp is a protein replacement therapy designed to deliver frataxin to mitochondria.
The FDA removed the partial clinical hold after review of data from Larimar's four-week, placebo-controlled Phase 2 dose exploration study.
The FDA decision will help the company to undertake the dose escalation to the 50 mg dose in its ongoing OLE study.
Interim data from the OLE study is expected in the fourth quarter of 2024.
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