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

Written by Ana Pena PhD | July 3, 2019

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.

About the Author

Ana Pena PhD Ana is a molecular biologist with a passion for communication and discovery. As a science writer, her goal is to provide readers, in particular patients and healthcare providers, with clear and quality information about the latest medical advances. Ana holds a Ph.D. in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in infectious diseases, epigenetics, and gene expression.

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Brian Kipf

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

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

Sylvie Pelletier

I have spms and would definitely be up to trying this therapy!

Louisa

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

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 Boren

MS patients need a cure not just another medication that does not cure.

Judith Kerfoot

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

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.

Bill Sargologo

Try the Edgar Cayce wet cell battery from the iodine source . Use gold and see if it works

Pam Rowgo

I would love to be in this trial. I live in Michigan. Maybe could do a trial at Cleveland Clinic or U of M.

Steph Allen

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 PhD

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

Any Wilson

Sign me up!

David valeo

This sounds like a study i would like to know more about.

Alicia Martin

Remyelination is the only answer to this MS.

Jack O’Hearn

I agree with Brian Kip’s. I have SPMS that continues to increase my disability.
Sign me up, too.

Darcy Zelinski

Can I receive information on how to be included in trial? I have SPMS

Amy Brewer

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.

David Boutwell

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.

Nancy

Yes I totally agree! -I would also like to sign up for the clinical trial

Conni Gardner

Where would we sign up for this trial? I am interested also.

Betty

I'm the same as Brian. Where do I sign up?

Tom

That's great but this doesn't regrow the nerve so this will only help some.

Robert Allen

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

Brian Gutschick

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.

Richard

I would try this.

Laura Higgins

This is an amazing break through with people suffering from nerve damage related illnesses.

María Isabel Maldonado

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.

Kimberly Panos

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.

Sarabjeet Singh

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

Tina Carantza

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.

Patrick Kelly

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?

Caitlin Anderson

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 ClinicalTrials.gov

Level 1s often are double blinded too ...

Nancy Molter

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

Debra Mckinley

Interested in this method

Teresa Stevens

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

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.

Garry Starkey

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.

Mike

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.

Kathy Kautz

This would be wonderful. Count me in for a trial.

Cas Messina

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?

Kendra

Where and how do you signup for the trial?!

Pam Johnston

I would love to be part of this MS. Study. It gives me hope.

Karl Wagner

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.