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Larimar Therapeutics Selected by FDA to Participate in START Pilot Program for Nomlabofusp in Friedreich’s Ataxia
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.
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.
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