Cannabidiol-based Oral Treatment Seen to Promote Remyelination in Mice, Trial Planned in MS Patients

Cannabidiol-based Oral Treatment Seen to Promote Remyelination in Mice, Trial Planned in MS Patients

EHP-101, a cannabidiol-based experimental therapy for multiple sclerosis, was able to recover myelin in damaged nerve fibers and lessen neuroinflammation in a mouse model of MS, data show.

Emerald Health Therapeutics, the manufacturer of EHP-101, also announced plans to open Phase 2 clinical trials in patients by the close of this year.

The data on EHP-101 were shared at the 29th Annual Symposium of the International Cannabinoid Research Society (ICRS), held June 30–July 3 in Maryland, and suggest that EHP-101 may be a potential remyelination therapy.

Results were presented in the poster “Effects of EHP-101 on inflammation and remyelination in murine models of multiple sclerosis.

EHP-101 is an oral formulation of VCE-004.8, a lab-made (or synthetic) molecule derived of cannabidiol (CBD), which constitutes a new chemical entity patented by Emerald. Cannabidiol is a natural substance found in cannabis (marijuana) and hemp plants, and one considered non-reactive and non-psychotropic.

According to Emerald, EHP-101’s potential benefits exceed other cannabidiol products owing to its greater activity via the cannabinoid receptors CB2 and PPAR-gamma. Prior research showed that these receptors help prevent inflammation and demyelination in the central nervous system.

The study presented at ICRS 2019 evaluated EHP-101’s activity in a mouse model of demyelination (induced by the agent cuprizone), showing substantial myelin loss in the brain after six weeks, and an inability to naturally recover from demyelination.

Emerald researchers reported that treatment with oral EHP-101 helped to speed myelin recovery, and at the same time eased neuroinflammation.

In two other MS mouse models — the experimental autoimmune encephalomyelitis (EAE) model, and Theiler’s murine encephalitis virus-induced (TMEV) — EHP-101 was also seen to prevent inflammation and myelin loss both in the spinal cord and brain.

Earlier studies in MS mouse models also demonstrated that the compound has promising neuroprotective effects that could prevent nerve cell damage.

“Restoring the myelin sheath around nerves, or remyelination, would be considered a ‘Holy Grail’ outcome in the treatment of MS,” Jim DeMesa, MD, Emerald’s CEO, said in a press release.

“Our new data demonstrate that EHP-101 can generate new myelin sheaths on the nerves damaged by MS, which is not reversible naturally in the disease. These preclinical data provide the first evidence of remyelination with our lead clinical-stage drug product candidate, and provide promising evidence for the possibility to treat, and potentially reverse, several forms of MS in the future,” DeMesa added.

Preclinical data suggest that EHP-101 “has the potential to be neuroprotective and disease-modifying,” Emerald reports on a webpage detailing EHP-101 in MS.

A Phase 1 trial in Australia (NCT03745001) is evaluating the safety, tolerability, and pharmacokinetics (distribution and elimination of a therapy by the body) of a liquid form of EHP-101 in healthy volunteers. If favorable, trial results are expected to support Phase 2 clinical studies in patients with MS and systemic scleroderma, expected to begin by the end of 2019.

The U.S. Drug Enforcement Administration (DEA) ruled in April that VCE-004.8 should not be classified as a controlled substance.

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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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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37 comments

  1. LuAnn Sullivan says:

    This is huge! Finally a substance that repairs nerve damage and provides Neuro protection. I hope this research is fast tracked so our neurologists can begin prescribing it rather than offer us immunosupressants that cause extreme disabilities if the patient stops taking them!

    • Jen says:

      Or just use premium cbd oil (lab tested & trusted by medics) like I am.. just had my annual MRI & no change or degeneration. So I believe its working for me & no prescription needed!

      • Lennon B Thompson says:

        Jen – How did you even get your Dr. to OK CBD oil??? I am on Ocrevus infusions 2x/yr, but have leg spasms almost daily. I have tried CBD oil in pill form and the legs feel ‘weak’ the following day. Is there a SPECIFIC CBD oil that you can refer? Many thanks……LBT

        • Kat says:

          I take a full spectrum 1000
          Looking for the highest possible
          Take it 2-3 times a day
          Stopped O when I almost killed me
          Never did the 6month dose after the first two 1/2 doses

          • Susan Woodcock says:

            I am interested in your experience with Ocrevis. My MS neurologist has been pushing me to take it. But I am not wanting to. I had a bad reaction to Rituxin. Any information you can share would be helpful.

      • Jennifer Stridinger says:

        I would love to know what brand cbd oil you are using…. I’ve seen many advertised but hard to tell which are legit. TIA

  2. Dale Degraffenreid says:

    Is this for PPMS? If so, will the trials be in the U.S.? My daughter has PPMS and Lupus. She needs lots of help.

  3. Carol says:

    This is great news! I would love to be part of the study. I currently use CBD salve for my arm/leg and it helps with the tingling. I used the CBD tincture to help when I get anxiety or my symptoms are bad or I’m just having a bad day in general. Works great.

  4. Nancy Bargoot says:

    This is something that has been long awaited!
    Had MS 43 years had been progressive for decades. How can I sign up for this trial!!

  5. Amy Penszynski says:

    Why can’t they just use real cbd from the real plant…why synthetic?…ughhh.
    That’s the maddening part.

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