Emerald Health Pharmaceuticals (EHP) has started patient enrolment for its Phase I clinical trial of EHP-101 for the treatment of patients with multiple sclerosis (MS) and scleroderma.
The randomised, double-blind, placebo-controlled trial is being carried out in Australia.
It will be conducted in two parts: a single-ascending dose phase (Part 1) and a multiple-ascending dose phase (Part 2).
During the first phase of the trial, the company is expected to enrol up to 64 healthy subjects who will receive EHP-101 or placebo in single-ascending oral doses.
A maximum of 40 healthy subjects will be included in the second phase and will be administered EHP-101 or placebo in multiple-ascending daily oral doses, as determined in Part 1.
The trial’s primary endpoints are to evaluate the safety and tolerability of EHP-101.
Its secondary endpoints include evaluation of the pharmacokinetic profile, food effects, and pharmacodynamic effects of EHP-101, as well as various biomarkers related to EHP-101’s mechanism of action and its potential for efficacy.
Top-line results from the trial are expected to be published next year.
Emerald Health Pharmaceuticals CEO Jim DeMesa said: “Our 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.
“We believe our novel, proprietary oral treatment represents a significant advancement in the treatment of patients with multiple sclerosis (MS) and scleroderma.
“The initiation of human studies is a major accomplishment as we continue to advance cannabinoid science and deliver on another important development milestone. Based on our recent pre-IND meeting with the US FDA, we believe the results from this Phase I study are likely to support Phase II studies in both MS and scleroderma.”
EHP-101 is an investigational oral drug formulation of a synthetic new chemical entity (NCE) derived from cannabidiol (CBD).