3 March 2020 - First-in-class product candidate in Phase 2 clinical development now has fast track and orphan designations.
Emerald Health Pharmaceuticals has been granted fast track designation from the US FDA for its lead clinical-stage product candidate, EHP-101, for the treatment of systemic sclerosis (SSc), a severe form of scleroderma.
EHP is currently initiating a Phase 2 clinical study for systemic sclerosis in Australia, New Zealand and the United States with EHP-101, an oral formulation of a patented, synthetic new chemical entity derived from cannabidiol. EHP previously received orphan drug designation in the US and EU for EHP-101 in the treatment of systemic sclerosis.