Pipeline

Candidate & Indication Preclinical Phase 1 Phase 2 Phase 3
Small Molecule
NS-189 US Major Depressive Disorder
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NS-189 US Angelman Syndrome
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NS-189 US Cognitive Impairment
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NS-189 US Irradiation-induced cognition
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NS-189 US Diabetes-related neuropathy
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NS-189 US Ischemic Stroke
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Cell Therapy*
NSI-566 US Amyotropic Lateral Sclerosis
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NSI-566 US Chronic Spinal Cord Injury
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NSI-566 China Ischemic Stroke
Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started

*Neuralstem corporate strategy is to seek partnerships/collaborations to fund the programs.

NSI-189:  Neuroregenerative Small Molecule

NSI-189 is the lead compound in our neurogenic small molecule drug discovery program. NSI-189 is being evaluated for the treatment of major depressive disorder (MDD).  Data suggest that NSI-189 works by promoting synaptogenesis or neurogenesis in the hippocampus; a different mechanism of action than currently marketed antidepressants.   Top-line results from an exploratory Phase 2 clinical trial were announced in July 2017.

Multiple data support NSI-189's neurogenic characteristics in preclinical models: Angelman syndrome, irradiation-induced cognitive impairment, neuropathy associated with Type 1 and Type 2 diabetes and ischemic stroke. Additionally, NSI-189 produced a concentration and time dependent increase in the magnitude of long-term potentiation (LTP), a measure of synaptic plasticity which is an in vitro biomarker of improved memory.

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NSI-566:  Cell Therapy

NSI-566, our lead cell therapy candidate, is a spinal-cord derived neural stem cell line. NSI-566 is being investigated for the treatment of Amyotrophic Lateral Sclerosis (ALS), AIS-A complete chronic spinal cord injury (cSCI) and ischemic stroke.

Our technology facilitates the isolation and large-scale expansion of regionally specific, human neural stem cells from all areas of the developing human brain and spinal cord. This enables the generation of physiologically relevant human neurons of all types. We believe that our stem cell technology will assist the body in producing new cells to replace malfunctioning or dead cells to treat disease and injury. Many significant and currently untreatable human diseases arise from the loss or malfunction of specific cell types in the body. Our stem cells may provide an effective method to protect such cell types and in certain cases to generate replacement cells from neural stem cells. We believe that protecting the healthy cells or replacing damaged, malfunctioning or dead neural cells with fully functional ones may be a useful therapeutic strategy in treating many diseases and conditions of the nervous system.

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