Forge Biologics Cleared for Clinical Trial of FBX-101, a Krabbe Disease Treatment


The FDA has recently cleared an Investigational New Drug (IND) application for FBX-101, allowing it to move into a Phase 1/2 clinical trial. This gene therapy was developed for the treatment of Krabbe disease, a severe form of pediatric leukodystrophy that is typically fatal by age two. As there is currently no approved treatment for this condition, this IND approval marks a large step in the right direction for patients.

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