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  • GC¡¤Hanmi submit IND apl. for new 'Fabry disease' drug
  • by Son, Hyung-Min | translator Kang, Shin-Kook | Aug 2, 2024 05:52am
to conduct Phase 1/2 clinical trials in the U.S.
Being developed as once-monthly subcutaneous injection formulation
GC Biopharma and Hanmi Pharmaceutical announced on July 1st that they have submitted Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Phase 1/2 clinical trials of ¡®(LA-GLA),¡¯ a treatment for Fabry disease that they are co-developing.

LA-GLA is an innovative new drug to treat Fabry disease. GC Biopharma and Hanmi Pharmaceutical are co-developing it as the 'world's first once-monthly subcutaneous dosing.'

Fabry disease is a rare disease inherited in an X-chromosome and is a type of lysosomal storage disease (LSD). It occurs when 'alpha-galactosidase A,' the enzyme needed to break down the glycolipid in the lysosome. It is a progressive, rare, incurable disease caused
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