Endece Granted New U.S. Patent for NDC-1308, Therapy to Induce Remyelination in MS

Endece was recently issued an additional U.S. patent for its lead investigational product, NDC-1308, being developed to induce remyelination in patients with multiple sclerosis (MS) and prevent disease progression.

Currently in late preclinical development, NDC-1308 is designed to repair the myelin sheath of demyelinated axons (nerve fibers), a major cause of neurodegenerative disorders like MS. The therapy is specifically targeted to heal motor neuron damage, and is intended for use either as a monotherapy or in combination with other disease-modifying agents to slow progression.

Remyelination is the process of coaxing oligodendrocyte precursor cells (OPCs) to form oligodendrocytes, cells able to produce new myelin sheaths on demyelinated axons in the central nervous system (CNS). This is a process naturally regulated in the body and tends to be very efficient in a healthy CNS. But in people with MS, remyelination becomes increasingly incomplete and in many patients eventually fails, leading to more progressive disease forms.

NDC-1308 works on a chain of key regulatory gene pathways responsible for the differentiation of OPCs and myelin synthesis. In preclinical models, it has been shown to effectively cross the blood-brain barrier, and to exert its effects on motor neurons in the brain and spinal cord.

“In addition to strengthening ENDECE’s intellectual property portfolio, this additional patent bolsters our position that remyelination is possible in patients with MS, and will help advance the clinical development programs for NDC-1308 and other potential treatments for neurodegenerative diseases,” James Yarger, PhD, chief executive officer of Endece, said in a press release. “In preclinical models, NDC-1308 readily crosses the blood-brain barrier and induces oligodendrocyte progenitor cells to differentiate into mature oligodendrocytes, which then synthesize and maintain the protective myelin sheath.

“Importantly, these studies demonstrated NDC-1308, an estradiol analog, gained this unique ability to induce remyelination while losing the estrogenic characteristics of estradiol.”

The newly issued patent, No. 9,364,486, is titled “6-Substituted Estradiol Derivatives for Use in Remyelination of Nerve Axons,” and specifically covers the drug’s potential remyelinating effects in the brain and spinal cord.

Endece has already received patents in Canada, Europe, China, Singapore, and Australia covering NDC-1308 for its potential in inducing remyelination. The drug has also been issued Composition of Matter and Use patents in the U.S. and in other major international markets.