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Larimar Therapeutics announced that the FDA has selected its therapy, nomlabofusp, for the START pilot program. This program aims to accelerate the development of treatments for rare diseases. Nomlabofusp is a novel protein replacement therapy targeting the root cause of Friedreich’s ataxia (FA) by delivering frataxin to mitochondria.
The selection was based on the therapy's potential for clinical benefit and its development readiness. The START program facilitates enhanced communication with the FDA, which can speed up pivotal study initiation and the path to a Biologics License Application (BLA), currently targeted for the second half of 2025. Interim data from an ongoing open-label extension study is expected in Q4 2024.
Larimar's participation in START could improve development efficiency through more frequent interactions with the FDA, ensuring high-quality, reliable data to support future applications.
Larimar Therapeutics (Nasdaq: LRMR) announced that the FDA has removed the partial clinical hold on their nomlabofusp (CTI-1601) program, aimed at treating Friedreich’s Ataxia (FA). This decision followed the review of data from a recently completed Phase 2 dose exploration study, which included 25 mg and 50 mg cohorts. The study showed that nomlabofusp was well-tolerated and demonstrated dose-dependent increases in frataxin levels. Larimar plans to escalate the dose to 50 mg in the ongoing open-label extension (OLE) study. Interim data from this study is expected in Q4 2024, with a Biologics License Application (BLA) submission targeted for the second half of 2025.
Larimar Therapeutics reported positive Phase 2 data for nomlabofusp in treating Friedreich's ataxia, with dose-dependent increases in frataxin levels. BLA submission expected in 2025, with FDA discussions ongoing. A financing round raised $161.8 million, extending cash runway to 2026. First patient dosed in OLE study with interim data due in Q4 2024.
