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.