YONGIN, South Korea, May 20, 2024
/PRNewswire/ -- GC Biopharma (006280. KS) and Novel Pharma
announced that its jointly developed MPS IIIA 'GC1130A' treatment
has received FDA IND approval.
With this approval, development of 'GC1130A' is expected to
accelerate with multinational clinical trials commencing this year.
Clinical trial sites have been set up in the US, Korea and
Japan, and focus of the trial will
center around proving the drug's safety and tolerability.
GC Biopharma and Novel Pharma have been co-developing ICV ERT
(intracerebral ventricular enzyme replacement therapy) for MPS IIIA
to address the lack of Heparan N Sulfatase expression in the
patient's body.
'GC1130A' also received ODD and RPDD designations from the FDA
and EMA during the pre-clinical phase on the back of robust safety
and efficacy profile.
Sanfilippo Syndrome (type A) is a genetic disorder that triggers
central nervous system damage by accumulating Heparan sulfate,
leading to a progressive damage. If left untreated, it may result
in a life-threatening outcome around the age of 15. With this
approval, MPS III type A could become the first and only treatment
option for patients with such disease.
GC Biopharma's representative further emphasized, "With this IND
approval, we can now enter phase 1 clinical and we will do our
utmost in new drug development to provide hope to patients
suffering from the 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