Emerald Health PharmaceuticalsÂ announced that it has begun enrolling healthy volunteers for a Phase 1 clinical trial evaluating the safety and tolerability ofÂ EHP-101,Â a potential cannabidiol treatment for multiple sclerosis (MS) and scleroderma.
The randomized, double-blind, and placebo-controlled study (ACTRN12618001390279p) will Â investigate the safety and pharmacokinetics (how the body processes a medicine) of EHP-101, a cannabidiol (CBD) derivative, given orally to healthy individuals in Australia.
The study is divided into two parts: a single-ascending dose (SAD) phase (part 1) and a multiple-ascending dose (MAD) phase (part 2). In part 1, up to 64 people will receive single ascending doses (between 0.91 and 200 mg) of liquid EHP-101 or a placebo. In part 2, up to 40 people will be given EHP-101 or placebo in multiple ascending daily doses for seven days, based on the results obtained in part 1.
Its primary goals, or endpoints, include assessing the safety and tolerability of EHP-101 in these volunteers. Incidence and severity of adverse events will be recorded and participantsâ€™ vital signs, physical condition, vision and heart health (assessed by cardiac telemetry, ECG and echocardiography) and biomarkers (troponin levels) will be measured.
Secondary goals are evaluations of the medicationâ€™s pharmacokinetic and pharmacodynamic (mechanism of action) profiles, food effects, and various biomarkers of the treatmentâ€™s mechanism of action and potential for efficacy. All measurements will be doneÂ before, during, and up to 30 days after the last dose is administered.
EHP-101 is modified to enhance the therapeutic benefits of CBD by increasing the activity of two important molecules â€” peroxisome proliferator-activated receptor-gamma (PPARÎł) and cannabinoid receptor type 2 (CB2) agonist â€” and one pathway â€” hypoxia inducible factor (HIF) pathway â€” capable of regulating neurodegeneration, the company reports in aÂ press release.
Multiple studies found that the activation of PPARÎł and CB2 molecules and the HIF pathway can reduce neuroinflammation and fibrosis, and may have a positive effect on myelination of the central nervous system.
â€śOur research and development team has demonstrated the unique mechanism of action of EHP-101 in preclinical studies, indicating the potential to treat deadly diseases which currently have no cure,â€ť Jim DeMesa, MD, chief executive officer of Emerald Health Pharmaceuticals, said in the release.
â€śWe believe our novel, proprietary oral treatment represents a significant advancement in the treatment of patients with multiple sclerosis (MS) and scleroderma,â€ť DeMesa added. â€śBased on our recent pre-IND [Investigational New Drug] meeting with the U.S. FDA, we believe the results from this Phase 1 study are likely to support Phase 2 studies in both MS and scleroderma.â€ť
The company expects to report top-line results from this Phase 1 trial in mid-2019.
EHP-101 was designated anÂ orphan drugÂ as a potential treatment of scleroderma by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
More information on this trial is available by contacting the Emerald Health at [emailÂ protected]