GC Biopharma/Novel Pharma's Sanfilippo Syndrome Therapy Obtains FDA IND Approval By Investing.com

YONGIN, South Korea, Could 20, 2024 /PRNewswire/ — GC Biopharma (006280. KS) and Novel  Pharma introduced that its collectively developed MPS IIIA ‘GC1130A’ remedy has acquired FDA IND approval.

With this approval, growth of ‘GC1130A’ is predicted to speed up with multinational medical trials commencing this yr. Scientific trial websites have been arrange within the US, Korea and Japan, and focus of the trial will focus on proving the drug’s security and tolerability.

GC Biopharma and Novel Pharma have been co-developing ICV ERT (intracerebral ventricular enzyme alternative remedy) for MPS IIIA to handle the dearth of Heparan N Sulfatase expression within the affected person’s physique.

‘GC1130A’ additionally acquired ODD and RPDD designations from the FDA and EMA through the pre-clinical part on the again of sturdy security and efficacy profile.

Sanfilippo Syndrome (sort A) is a genetic dysfunction that triggers central nervous system injury by accumulating Heparan sulfate, resulting in a progressive injury. If left untreated, it might end in a life-threatening end result across the age of 15. With this approval, MPS III sort A may change into the primary and solely remedy choice for sufferers with such illness.

GC Biopharma’s consultant additional emphasised, “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. (previously generally known as Inexperienced Cross Company) is a biopharmaceutical firm that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma Corp. is without doubt one of the main plasma protein and vaccine product producers globally and has been devoted to high quality healthcare options for greater than half a century.

This press launch could comprise  biopharmaceuticals  in forward-looking statements, which categorical the present beliefs and expectations of GC Biopharma’s administration. Such statements don’t signify any assure by GC Biopharma or its administration of future efficiency and contain identified and unknown dangers, uncertainties and different elements. GC Biopharma undertakes no obligation to replace or revise any forward-looking assertion contained on this press launch or every other forward-looking statements it might make, besides as required by legislation or inventory change rule.

GC Biopharma Corp. Contacts (Media)

Sohee Kimshkim20@gccorp.com

Yelin Junyelin@gccorp.com

Rachel Kimrachel.kim@gccorp.com