The first patients have been dosed in a Phase 2a clinical trial of EHP-101, Emerald Health Pharmaceuticals‘ investigational cannabidiol-derived treatment for diffuse cutaneous systemic sclerosis (dcSSc), the company announced.
So far, the randomized, placebo-controlled trial (NCT04166552) has enrolled two of 36 patients, and activated six of an anticipated 30 study centers across Australia, New Zealand, and the U.S. The trial is continuing to recruit; more information on locations and contacts can be found here.
Among other criteria, eligible dcSSc patients must be adults 18–70 years old who have not received new or increased doses of immunosuppressants within three months prior to screening.
“The absence of approved treatment options for systemic sclerosis represents an urgent medical need and we are pleased to offer a clinical trial option for a new and promising treatment to patients with systemic sclerosis, even during these difficult and unprecedented times when recruitment and screening of patients for study eligibility was limited due to local regulations around the current pandemic,” Joachim Schupp, EHP’s chief medical officer, said in a press release. “The initiation of our Phase 2 study of EHP-101 represents an important milestone in the clinical advancement of our lead product candidate.”
Participants will be randomly assigned to either a low or high dose of EHP-101 or a placebo, both taken orally once or twice a day over 84 days. The trial’s primary outcome measure is the incidence and severity of treatment-emergent adverse events at the end of the 28-day follow-up period. In addition to safety assessments, the study will also evaluate EHP-1o1’s preliminary efficacy and pharmacokinetics — movement of a therapy into, through, and out of the body.
Emerald Health expects to have preliminary results early next year and anticipates study completion by mid-2021.
The active ingredient in EHP-101 is called VCE-004.8, a synthetic cannabidiol-derived molecule without psychoactive properties.
Both the U.S. Drug Enforcement Administration and Canada’s Controlled Substances Directorate recently cleared the use of VCE-004.8, meaning the two agencies do not view this compound as a controlled substance.
Cannabidiol has been shown to reduce pain and inflammation by regulating nerve cell activity through the body’s endocannabinoid receptors.
EHP-101 is designed to have a stronger therapeutic effect than other cannabidiol-derived products by activating multiple anti-inflammatory pathways. This is accomplished by activating the cannabinoid receptor type 2 and peroxisome proliferator-activated receptor gamma, and by targeting the hypoxia-inducible factor pathway, which is involved in fibrotic diseases such as scleroderma.
Both the U.S. Food and Drug Administration and the European Medicines Agency have granted EHP-101 orphan drug status for the treatment of systemic scleroderma. The FDA has also granted fast track designation for the same indication. These designations provide a number of financial and administrative benefits to help bring a treatment candidate to the market.
Emerald Health is also preparing to start a Phase 2 study of EHP-101 for the treatment of multiple sclerosis later this year.
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