The active ingredient in EHP-101 — known as VCE-004.8, derived from synthetic cannabidiol — is not classified as a controlled substance under Canada’s Controlled Drug and Substance Act (CDSA), the potential treatment’s developer, Emerald Health Pharmaceuticals, reported.
VCE-004.8 is a non-reactive, non-psychotropic synthetic compound derived from cannabidiol, or CBD, a non-psychoactive compound of the cannabis plant. EHP-101 is an investigational therapy for people with systemic scleroderma and multiple sclerosis.
This decision by Canada’s Controlled Substances Directorate follows a similar determination by the U.S. Drug Enforcement Administration (DEA) in April 2019.
Both provide the company “more flexibility in advancing our clinical program globally,” Jim DeMesa, MD, president and CEO of Emerald, said in a press release.
VCE-004.8 is designed to limit inflammation in scleroderma by activating two protein receptors — peroxisome proliferator-activated receptor gamma (PPARɣ) and cannabinoid receptor type 2 (CB2). The therapy also targets the hypoxia-inducible factor (HIF) pathway that is involved in fibrotic (scarring) diseases such as scleroderma.
Being classified as a non-controlled substance helps to lower the costs of manufacturing EHP-101, since those facilities will not need special certifications for handling the compound. It also helps in conducting both preclinical and clinical studies, as it eases administrative requirements.
Emerald has launched a Phase 2a clinical trial (NCT04166552) to test the therapy’s safety, tolerability, pharmacokinetics and preliminary efficacy in 36 adults with diffuse cutaneous scleroderma. (Pharmacokinetics refers to a compound absorption, distribution, metabolism, and excretion.)
Participants will be randomized to low and high doses of EHP-101 or a placebo, taken once or twice a day.
The study’s main goal is to assess the therapy’s safety. Efficacy will be measured through questionnaires and standardized clinical tests, including the American College of Rheumatology composite response index in diffuse cutaneous Systemic Sclerosis.
The trial, set to take place in Australia, New Zealand, and the U.S., is not yet recruiting patients. More information on contacts and locations will be available here.
“These determinations by Canada and the US also highlight the important difference between our novel molecules compared to natural cannabinoids. We plan to continue seeking these determinations in various countries as we expand our clinical program throughout the world,” DeMesa said.
Following positive results in a mouse model of scleroderma, a Phase 1 trial (NCT03745001) showed that EHP-101 was well-tolerated in healthy volunteers. Mild-to-moderate side effects were reported at higher doses, which Emerald said were much higher than the likely doses to be used with scleroderma patients.
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