Emerald Health Pharmaceuticals’ lead cannabinoid-derived treatment candidate, EHP-101, has shown potential to prevent skin and lung tissue scaring in a mouse model of systemic sclerosis, the company reports.
Emerald also claims that EHP-101’s therapeutic activity is similar or superior to that seen in ajulemic acid, also known as lenabasum — a potential treatment being developed by Corbus Pharmaceuticals that is currently in Phase 3 trial, called RESOLVE-1 (NCT03398837), in people with diffuse cutaneous systemic sclerosis.
RESOLVE-1 is enrolling patients at sites across the U.S.; a separate Phase 2 study has moved into an open-label extension phase.
On its website, Emerald announced plans to open a Phase 1 clinical trial later this year in Australia, evaluating EHP-101’s safety and tolerability based on its positive preclinical data.
Data were presented at the 28th Annual Symposium of the International Cannabinoid Research Society (ICRS) held recently in Leiden, The Netherlands. Adela Garcia, PhD, announced results of the study, “Oral EHP-101 Alleviates Skin and Lung Fibrosis in Bleomycin Model of Scleroderma.”
EHP-101, previously known as VCE-004.8, is derived from cannabidiol (CBD), which is extracted from the cannabis plant. It has been engineered to strengthen the therapeutic potential of CBD by promoting cellular signals that can prevent inflammation in the central nervous system, and tissue-scaring mechanisms in the periphery.
The U.S. Food and Drug Administration designed EHP-101 an orphan drug as a potential scleroderma treatment in October 2017, and the European Medicines Agency followed with a similar designation several months later.
Orphan drug status is given to potential therapies that have demonstrated promise to treat rare diseases, and provide support for a faster schedule of development and review for approval.
Researchers investigated oral EHP-101 given to mice in the so-called bleomycin-induced skin fibrosis disease model.
The treatment reduced the thickness of the skin and prevented the infiltration of pro-inflammatory cells in a dose-dependent manner — higher doses reflected greater effects, the research team reported. In addition, treatment significantly reduced the levels of several major genes and biomarkers known to be involved in fibrosis and inflammation.
Interestingly, the cannabinoid-derived treatment also supported the recovery of blood vessels from damage induced by bleomycin. This particular feature differentiates EHP-101 from similar therapies such as ajulemic acid, the company said.
“Our scientists have demonstrated EHP-101’s potential … as a disease-modifying treatment for scleroderma,” Jim DeMesa, MD, CEO of Emerald Health, said in a press release.
EHP-101 is also seen as a potential treatment for multiple sclerosis based on preclinical work in models of that disease, the company said.
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