ABOUT NDC-1308

In preclinical models, NDC-1308 activates the production of genes responsible for progenitor cell differentiation, leading to the production of myelin, the protective covering that is damaged in patients with MS. Specific steps include: Progenitor cells (1) mature into pre-oligodendrocytes, (2) which then become pre-myelinating oligodendrocytes, (3) and ultimately, myelinating oligodendrocytes (4).

NDC-1308

NDC-1308 is a novel chemical entity, currently in late preclinical development, that is designed to address one of the root causes of MS by inducing oligodendrocyte progenitor cells (OPCs) – the precursors of oligodendrocytes – to mature into oligodendrocytes, the cells that synthesize and maintain the myelin sheath.

Studies in animal models suggest that NDC-1308 significantly induces remyelination of demyelinated nerves by causing a dramatic up regulation of genes in signaling pathways involved in inducing OPC differentiation, leading to myelin sheath production.

Our validation studies, supported in part by a research grant from the National Multiple Sclerosis Society, have reproducibly demonstrated the induction of remyelination in a mouse model of MS in which the neurotoxicant cuprizone was used to remove the myelin sheath from the axons (nerve fibers) of mice.

NDC-1308 is a small molecule that readily crosses the blood-brain barrier, allowing it to reach the tissues in the brain and spinal cord where promoting myelin sheath production is needed. NDC-1308 is being developed for potential use either alone or in combination with other MS therapeutics that currently slow the progression of the disease.

A manufacturing process for NDC-1308 active pharmaceutical ingredient (API) production has been developed in compliance with good manufacturing practices (GMP). Similarly, we have developed a stable formulation for NDC-1308 that delivers the drug to the brain and spinal cord.

MULTIPLE SCLEROSIS (MS) IS AN UNPREDICTABLE, OFTEN DISABLING DISEASE OF THE CENTRAL NERVOUS SYSTEM THAT INTERRUPTS THE FLOW OF INFORMATION WITHIN THE BRAIN, AND BETWEEN THE BRAIN AND BODY.

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