Neuracle Science's New Antibody Approved for Phase 1
Neuracle Science's New Antibody Approved for Phase 1
  • Bong Young Choi
  • 승인 2021.11.06 08:40
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NS101, first-in class targeting FAM19A5
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Neuracle Science, a Seoul-based biopharmaceutical developing neuropeptides and antibody therapeutics to treat neurodegenerative diseases, announced on October 28th that the Clinical Trial Application (CTA) of NS101 phase 1 was approved.

The CTA was submitted to the Health Canada in September 2021. This phase 1 clinical trial will be conducted with about 60 healthy individuals in Canada, to confirm the safety, tolerability, pharmacokinetics, and immunogenicity of NS101.

Preclinical studies have shown that NS101 has the neuroprotective effects (prevention of degeneration and promotion of regeneration).

NS101 has a new mechanism of action that regenerates the central nervous system by promoting structural activation of synaptic connections. It is being developed as a treatment for various central nervous system diseases such as Alzheimer's disease,

NS101's new drug target, FAM19A5, was discovered by Neuracle Science through bio big data and bio-informatics to find optimized drug targets. FAM19A5 is a secretary protein that is predominantly expressed in the brain (so-called, a neurokine or brain-specific chemokine) and inhibits the growth of neurites and synaptic connections. NS101 is an antibody that specifically binds to FAM19A5 and promotes the recovery of nerve functions by removing it.

"NS101 has new mechanism to promote nerve regeneration by removing proteins that inhibit nerve connection.” said Jae-young Sung, CEO of Neuracle Science. "We are going to start global clinical trials and also currently discussing technology transfer with multiple global pharmaceutical companies." he added.



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