Larimar Therapeutics, Inc. (LRMR) announced on Tuesday that the FDA has lifted the partial clinical hold on its lead program, CTI-1601, also known as nomlabofusp. This program is focused on treating patients with Friedreich's Ataxia.
Nomlabofusp is a protein replacement therapy aimed at delivering frataxin to mitochondria.
The FDA's decision followed a review of data from Larimar's four-week, placebo-controlled Phase 2 dose exploration study.
This clearance will allow the company to escalate dosing to 50 mg in their ongoing OLE (open-label extension) study.
Interim data from the OLE study are anticipated in the fourth quarter of 2024.