Emerald Health Pharmaceuticals has completed the Phase I study of cannabidiol (CBD)-derived drug candidate EHP-101 for the treatment of multiple sclerosis (MS) and systemic scleroderma (SSc).
HP-101 is made of an oral, synthetic aminoquinone derivative of CBD.
It is said to have a multi-pronged mechanism of action, including agonist activity towards peroxisome proliferator-activated receptor gamma and cannabinoid receptor type 2. Both receptors are known to be therapeutic targets for MS and also SSc.
The Phase I clinical trial assessed the safety, pharmacodynamics, pharmacokinetics and exploratory biomarkers of the product. It was intended to facilitate Phase II studies in MS and SSc indications.
It was performed in 104 healthy volunteers who were randomised across eight single ascending dose (SAD) groups and four multiple ascending dose (MAD) arms.
Each SAD group received a single dose of EHP-101 or placebo. The dose ranged from 0.9mg to 185mg and increased with each group.
In the MAD portion, each group was given EHP-101 or placebo in multiple oral doses ranging from 20mg to 100mg per day for seven days.
EHP-101 was observed to be well tolerated at all doses, demonstrating mild to moderate adverse events with increasing dose levels.
Emerald Health said that the highest doses were above the expected therapeutic dose for MS and SSc, facilitating adjustment of doses in the future Phase II studies.
Emerald Health Pharmaceuticals chief medical officer Joachim Schupp said: “The safety and tolerability profile of EHP-101 in our large first-in-human study allows us to define an appropriate dosing regimen and proceed with our planned Phase II studies in multiple sclerosis and systemic scleroderma patients.”
The company intends to report Phase I top-line data by the end of this year.