REYON Pharmaceutical (co-CEOs Jeong Soon-ok and Yoo Yong-hwan) announced on October 28 that its partner and biostartup, Neuracle Science (CEO Seong Jae-young), obtained approval from the Department of National Health and Welfare of Canada on the Phase 1 clinical trial protocol for NS101, an antibody drug for degenerative brain disease.

NS101 is a first-in-class drug for Alzheimer’s disease, and it is the first antibody drug for dementia developed in Korea to undergo a global clinical trial. 

NS101 has a novel mechanism of action in that it promotes structural activation of synaptic junctions for regeneration of the neurons in the central nervous system, based on which it is being developed as a treatment for various diseases of the central nervous system such as Alzheimer’s, amyotrophic lateral sclerosis (ALS, commonly known as Lou Gehrig’s disease), and traumatic spinal cord injury.

REYON Pharmaceutical signed a joint development agreement with Neuracle Science in 2018 and made an investment to acquire a stake worth KRW 10 billion.

Since then, the two companies have been jointly developing NS101, with REYON Pharmaceutical having the exclusive license and distribution rights in Korea. The recent approval for a clinical trial in Canada has helped pave the foundation for a clinical study in Korea. 

“It brings me great pleasure that our partner, Neuracle Science, has successfully taken the first step toward a Phase 1 clinical trial through our joint development. We will do our best to achieve stellar results based on continued cooperation,” said Yoo Yong-hwan, co-CEO of REYON Pharmaceutical. 

Seong Jae-young, CEO of Neuracle Science, said, “NS101 is a dementia treatment agent with a new mechanism of action to promote nerve regeneration by removing the neurosynaptic inhibitory protein, which is the first in the world. In addition to starting a global clinical trial, we are discussing licensing with multiple global pharmaceutical companies with which we have signed a non-disclosure agreement, and based on these achievements, we plan on pursuing IPO on KOSDAQ next year.” 

Meanwhile, REYON Pharmaceutical also signed a contract to jointly develop and commercialize an AAV-based gene therapy agent with Neuracle Genetics, a subsidiary of Neuracle Science, in 2020 and gained exclusive global production and supply rights. The plan is to obtain approval of the clinical tirla protocol and kick off a Phase 1 clinical trial in the second half of 2022.