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

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myelin damage and 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.

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  1. Chuck Stump says:

    we need this to be fast tracked.
    The FDA is lagging the world in stem cell treatment.
    Israel is doing HSCT for anybody.
    FDA is still arguing who can take part in the next “not funded yet” study to see if maybe sometime 10 to 20 years down the road a new therapy (probably for RRMS) may be able to treat some random symptom with another pill for $10,000/month. We need any treatment like this NOW, please.

  2. ken bloom says:

    Obviously a step in the right direction. Realistically, this is still years away (if at all), but at least it is progress. Only about 1 in 5000 drugs in preclinical trials get FDA approved, and the process is long, but we can hope that this becomes one of them and that clinical trial results warrant fast track status.

  3. TracyM says:

    I’ve progressed to SPMS. Currently, I’m in a hospital bed at home. My right hand & wrist are now affected;?my legs, feet and ankles do not work- at all. Except for the spascisity jerking. Will this be available for someone like me? I’m not on ANY DMD’s, I’m only being treated for symptom management i.e.; pain (Norco), spascisity (Baclofen. sp?) and helping with alertness by using (Provigil). I hope there will be a fast track for this Mefication!!

    • Robert says:

      Sorry to hear that Your MS has gotten this bad but hang in there.I think HSCT would probly benefit you in your condition 🙏👍.I would talk to your doctor about this procedure.

  4. Harry Crawford says:

    I believe the FDA is in the pharmaceutical companies pockets. Ive been waiting for ocrelizumab another proven drug to be released. It’s become a joke of an organization. They’ve allowed multiple meds to be introduced to later recall or strongly advice against them. But the really important ones that would change the pharmaceutical work as we know it had been held up for no apparent reasons. Ive talked to the company who makes ocrelizumab and they haven’t a Clue what’s taking so long. Although they did say that the FDA tends to Drea their feet alot. I’ll bet if one of them had MS the meds would be available much sooner. Although again I believe it had something to do with the pharmaceutical companies involvement and the mighty dollar.

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