NervGen to Advance NVG-291 as Potential Remyelination Therapy for MS

NervGen to Advance NVG-291 as Potential Remyelination Therapy for MS

NervGen wants to advance the development of NVG-291, its lead investigational therapy for spinal cord damage, as a potential remyelination treatment for multiple sclerosis (MS), the company announced.

Following preclinical data showing that NVG-291 promotes myelin repair and regeneration of damaged nerves in animal models of spinal cord injury and MS, the compound has attracted pharma’s attention as a potential therapy for these and other neurodegenerative conditions.

NVG-291 is based on NervGen’s proprietary technology that inhibits the protein tyrosine phosphatase sigma (PTPσ), a neural receptor that inhibits nerve regeneration. It works in regions of scarring that result from nerve damage. Following such damage, the body responds with natural protective mechanisms, some of which prevent or inhibit regeneration of the nervous system — including the one mediated by PTPσ.

Blocking PTPσ with NVG-291 has been shown to promote regeneration of damaged nerves, improving nerve function in animal models for various medical conditions, according to NervGen.

Until now, NervGen has focused its efforts on exploring NVG-291 for the treatment of spinal cord injury. It plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2019. If that IND is approved, the company expects to initiate a Phase 1 clinical trial in early 2020 to demonstrate the therapy’s safety in humans.

Now, encouraged by the promising results, the company plans to move NVG-291’s pipeline forward, and include other target indications such as MS, peripheral nerve injury, and heart attack.

“As we advance our lead drug candidate, NVG-291, towards a Phase 1 clinical trial in Q1 2020 for spinal cord injury, we are leveraging the potential for our drug to also promote nerve remyelination as a therapy for MS,” Bill Radvak, NervGen’s executive chairman, said in a press release.

Multiple studies with animal models of several conditions have confirmed the benefit of a PTPσ-targeting compound known as intracellular sigma peptide (ISP). NVG-129 is a molecule that closely resembles ISP (an analogue) — it’s identical in shape but different in composition.

In MS mouse models, ISP was seen to stimulate the production and migration into MS lesions of oligodendrocyte-precursor cells (OPCs), a type of cell involved in myelin repair and regeneration. It enhanced remyelination of damaged nerves, lessened neuroinflammation, and helped mice to recover part of their functional abilities.

At the molecular level, ISP was seen to increase specific protein-cutting enzymes (proteases) that digest and break down glial scar tissue, which would otherwise keep nerves from regenerating.

“Recent positive reaction from the pharma community to the compelling data we have for a number of indications, including MS, has presented a clear opportunity for the Company to become an important participant in this large and dynamic segment of neurodegenerative diseases management. Importantly, the clinical data from our planned Phase 1 trial will provide us with key foundational knowledge that is transferrable to multiple indications for developing NVG-291,” Radvak said.

NervGen’s technology was developed in the laboratory of Jerry Silver, PhD, a professor at Case Western Reserve University in Cleveland. Silver is a leading researcher in spinal cord injury and regenerative medicine.

Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
Ana is a molecular biologist with a passion for discovery and communication. As a science writer she looks for connecting the public, in particular patient and healthcare communities, with clear and quality information about the latest medical advances. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in genetics, molecular biology, and infectious diseases
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  1. Brian Kipf says:

    As a person with PPMS I believe the only real way to win with MS is in remyelination. Where do i sign up for this trial?

    • Marjorie Meurn says:

      I agree! I have ppms too
      & believe this would help us immensely! I would like to be a part of this trial!

    • Louisa says:

      I agree! I would gladly participate in the 2020 trial!
      I have scar tissue on my spine that contributes to pain and mobility!
      At the age of 51 I no longer look for a cure for MS. I only pray for remyelination and body function restoration.

      • joseph scordo says:

        iam 62 yr old male with M S I cant walk I use a lift and wheelchair I would love to join ur study thank u

      • Peggy,
        Remyelination would allow MS to be treated like other chronic diseases, reversing some damage while still searching for causes of the disease which if found, a potential cure.

      • Rebecca Klipp says:

        Even if there was a cure it wouldn’t help those of us who already have MS. I’m secondary progressive and bedridden. Both legs are paralyzed and my dominant hand and arm barely move. Remyelination is the only thing that’s going to help.

      • Steph Allen says:

        Same here! I’m just outside Detroit and I would travel to the clinic to do it, I can work remotely… 38, diagnosed in 2017. I’m a firm believer in science, and a former dart player who would do anything to get the feeling in my throwing hand back.

    • Ana Pena says:

      Dear readers,

      Thank you for your feedback and interest. As far as I know there is no info yet as to where to apply for this trial. It may be worth to remember that the study is not approved by FDA yet. I think the best is to keep up with NervGen’s news on their official site. From our side, we will do our best to keep you posted on any updates. I hope this helped, let me know if you have any more questions.

      Happy weekend to you all,

      Ana Pena

  2. Amy Brewer says:

    I am also a person with PPMS. I am currently on ocrevus infusions. Although ocrevus will slow progression it doesn’t help improve situation. Where do i sign up for remylenation.

  3. David Boutwell says:

    I have been labeled SPMS and have gone from walking with a cane to rolling with a wheelchair in the last four years. MRIs reveal spinal cord demylation is the primary culprit. Please respond as to whom I speak with or where do I sign up for this trial.

  4. Robert Allen says:

    I have was diagnosed in 2013 with PPMS. I went from a cane to arm crutches to wheelchair in less than a year, DR. re-diagnosed me with RRMS and in a wheelchair, 4 years now. I agree remyelination is the key for MS. I would like to sign up for clinical trials

  5. Brian Gutschick says:

    I would love to be a part of this study. I have RRMS with constant pain in my legs. Severity of pain ranges from a 5 to 7 daily. Some days I am up to a 9 in pain level.

  6. María Isabel Maldonado says:

    Hi. Ir you hace más nothing Go yo remilienizate you. If you losse Melina you losse it. Any pharma or medicación gonna repair. The thing is take all the medicines for the condición and never think all gonna be like after.

  7. Kimberly Panos says:

    I really would like to be involved in NVG-291 trial. Where do I sign up? 13 years RRMS with emphasis on the relapsing. Failed with Copaxone, Rebiff. Tysabri got me active again until JCV was detected then 3x over limit after 47 infusions. Tried Plegridy, but the auto-injector malfunctioned more than it worked. On Tecfidera for 4+ years and not still tolerating it well. I still have flushing and rashes while on it, as well as disease progression while taking it.

  8. Sarabjeet Singh says:

    Remylytion in ms is a great victory waiting for it whosoever is in resrearch salute to him or her👍

  9. Tina Carantza says:

    I also am interested in joining in a phase 3 study. I have SPMS and am anxious to try anything that could possibly regain my ability to walk before I expire.

  10. Patrick Kelly says:

    I am a PPMS sufferer and have completed HSCT in 2015 with no new symptoms since. I would like to know how I may be able to get into the trial for this new medication?

  11. Caitlin Anderson says:

    Thanks for article. Notebthere’s a BIG IF in the story. FDA has to approve, centers need funding, and there will be criteria patients must meet (age, EDSS, etc). Having been in a Level 1, best thing is to watch

    Level 1s often are double blinded too …

  12. Nancy Molter says:

    I’m 55 with PPMS ….. probably now SPMS. Diagnosed January 1994. Can’t wait for a re-myelination drug ! I want my mobility back !

  13. Teresa Stevens says:

    Remyelination is the most promising therapy in my opinion. I’m 63 years old with ppms so I doubt they’d consider me (they did not for Ocrevus, for example, as well as others based on age alone) but I am very anxious to follow the trials.

    • Mike says:

      That’s ridiculous that they based it on your age it’s all about money your a person that deserves ever option out there to make you feel better.

  14. Garry Starkey says:

    An exciting development addressing damaged nerves and the loss of function. For MS sufferers I agree that remyelination of tatty nerves is key to restoring the situation.

  15. Mike says:

    I am sick of reading about mouse models and new orals to slow relapses we need this drug now. Someone like myself and others want to walk again. I pay 65,000 a year for Ocrelizumab. Lets get moving on this ASAP.

  16. Cas Messina says:

    I am an advocate for natural treatments as opposed to drugs normally, however if this potentially will reverse some effects, I’m all in. How do we find out about trials?

  17. Karl Wagner says:

    I’m in! I’m 41, diagnosed in 2017 and currently on Ocrevus. It’s doing well, but the Optic Neuritis is not being cured. I’d love to be able to see well again.

  18. David Bonanno says:

    This is exciting news. I have PMS and remyelination would prevent permanent axonal damage.
    I would also like to participate in the trial.

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