- Co-development of innovative new drug for the treatment of
Fabry disease as "the world's first once-monthly subcutaneous
treatment"
- Improves efficacy compared to existing treatment for kidney
function, vascular disease, and peripheral nerve disorders
YONGIN, South Korea,
Sept. 3,
2024 /PRNewswire/ -- GC Biopharma announced that its
collaborative project for Fabry treatment 'LA-GLA'
(GC1134A/HM15421) with Hanmi Pharmaceutical has received
Investigational New Drug (IND) clearance from the U.S. Food and
Drug Administration (FDA) for a Phase 1/2 clinical trial.
LA-GLA is an innovative new drug for the treatment of Fabry
disease as the world's first once-monthly subcutaneous treatment,
which is being co-developed by GC Biopharma and Hanmi
Pharmaceutical. This clinical trial aims to evaluate safety,
tolerability, pharmacokinetics, and pharmacodynamics of LA-GLA in
patients with Fabry disease.
Fabry disease is a rare genetic disorder linked to the X
chromosome and classified as a type of Lysosomal Storage Disease
(LSD). It results from a deficiency in the enzyme
alpha-galactosidase A, which is essential for breaking down
glycolipids in lysosomes. The accumulation of glycolipids due to
this deficiency leads to cellular toxicity and inflammatory
responses, progressively damaging multiple organs and potentially
leading to severe outcomes, including death.
Currently, Fabry disease is treated with Enzyme Replacement
Therapy (ERT) which involves the intravenous administration of a
recombinant enzyme. However, this treatment method requires
patients to visit the hospital every two weeks for an infusion,
leading to inconvenience. Moreover, the current method has
limitations, including the burden of prolonged intravenous therapy
and insufficient efficacy in preventing the progression of kidney
disease.
LA-GLA is an 'innovative enzyme replacement therapy" addressing
the limitations of existing treatments. It significantly improves
convenience with a once-monthly subcutaneous injection regimen. In
preclinical studies, LA-GLA not only improves kidney function but
also demonstrated superior efficacy in managing vascular disease
and peripheral nerve disorders compared to existing therapies.
Based on these promising results, it was designated as an Orphan
Drug (ODD) by the U.S. FDA this past May.
GC Biopharma and Hanmi Pharmaceutical commented, "This
collaboration integrates the latest FDA-mandated clinical protocols
and leverages the specialized technical expertise of both
companies, enabling a rapid transition into the clinical phase."
Further added, "Based on our expertise and knowledge of developing
new treatments for Lysosomal Storage Disease (LSD), we will do our
utmost to create new treatment options to patients suffering from
Fabry disease."
About GC Biopharma Corp.
GC Biopharma Corp. (formerly known as Green Cross Corporation)
is a biopharmaceutical company that delivers life-saving and
life-sustaining protein therapeutics and vaccines. Headquartered in
Yongin, South Korea, GC Biopharma
Corp. is one of the leading plasma protein and vaccine product
manufacturers globally and has been dedicated to quality healthcare
solutions for more than half a century.
This press release may contain biopharmaceuticals
in forward-looking statements, which express the current beliefs
and expectations of GC Biopharma's management. Such statements do
not represent any guarantee by GC Biopharma or its management of
future performance and involve known and unknown risks,
uncertainties and other factors. GC Biopharma undertakes no
obligation to update or revise any forward-looking statement
contained in this press release or any other forward-looking
statements it may make, except as required by law or stock exchange
rule.
GC Biopharma Corp. Contacts (Media)
Sohee Kim
shkim20@gccorp.com
Yelin Jun
yelin@gccorp.com
Rachel Kim
rachel.kim@gccorp.com
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SOURCE GC Biopharma