SCIENCE & TECHNOLOGY
Vision for the Future
Pipeline
We will grow into a world-class company in the field of
developing treatments for intractable brain diseases.
| Candidate | Indication | Pre clinical | Phase I | Phase II | Phase III | IP |
|---|---|---|---|---|---|---|
| NV01-A02 | Autism spectrum disorder |
Proceeding
|
KR, PCT, USA, EU, China, Japan | |||
| Fragile X syndrome |
Proceeding
|
KR, PCT, USA, EU, China, Japan | ||||
| NV01-A03 | Autism spectrum disorder |
Proceeding
|
KR, PCT, USA, EU, China, Japan | |||
| NV01-O62 | Autism spectrum disorder |
Proceeding
|
KR, PCT | |||
| NV01-E01 | Autism spectrum disorder |
Feasibility study
|
||||
NV01-A02
NV01-A02 was discovered through drug repositioning strategy using transcriptomic data analysis of samples obtained from autistic
patients and animal models. Features of the pipeline includes simultaneous and selective regulation of several neurotransmitter
receptors responsible for the modulation of social interaction in the brain, which is known as multi-target action.
It has been previously approved as a CNS medication; therefore, no safety and CNS penetration issues exist. PCT and individual
country patent application has been submitted. For phase 2 study IND filing, we completed the preclinical studies, and now we are
conducting formulation study and are preparing the clinical study planning. Recently, based on this multi-target action mechanism,
the US FDA approved NV01-A02 as an orphan drug designation for Fragile X Syndrome.
NV01-A03
NV01-A03 is originally derived from big data analysis of data obtained from human autism sample as and animal models of autism.
NV01-A03 acts on a variety of receptor subtypes, which are known to be associated with ASD etiology and pathophysiology.
Interestingly, NV01-A03 also increases the hormone related with social interaction both in human and animals.
NV01-A03 dose-dependently improved deficits in social interaction, ameliorated repetitive behavior,
and hyperactivity in ASD mouse models through intraperitoneal and oral administration. We are now preparing phase 2
clinical trial in the EU.
NV01-062
NV01-062 is a small molecule and an NCE used as a therapeutic against ASD. NV01-062 controls various physiological functions through
multi-target regulation. NV01-062 increases endogenous agmatine, known for its neuroprotective, anti-inflammatory,
antioxidant and anti-depressant properties, by inhibiting agmatinase. NV01-062 also acts on a variety of receptors.
NV01-062 improved social deficit, ameliorated repetitive behavior and hyperactivity in ASD mice models through
intraperitoneal administration. Based on these preclinical data, we are preparing for non-clinical study.
NV01-E01
NV01-E01 is an electroceutical treatment that addresses neurodevelopmental disorders through non-invasive trigeminal
nerve stimulation. We are conducting joint research and development with a company specializing in electroceutical R&D
and are in the process of exploratory clinical trials. We expect to create synergistic effects by developing a
combined administration protocol of our chemical drug and electroceuticals.
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