EHP-101 Phase 2a Trial Cleared to Move to High Dose Groups
First dose was well tolerated, with no serious treatment-related side effects reported
A Phase 2a clinical trial testing the oral cannabidiol-derived medication EHP-101 in people with diffuse cutaneous systemic sclerosis can proceed to the higher dose groups, the therapy candidate’s developer Emerald Health Pharmaceuticals (EHP) announced.
The study is taking place in the U.S., including Puerto Rico, as well as Australia, and New Zealand.
“We look forward to reporting the full interim analysis of this study in early 2023. We are working to secure the funds necessary to continue the next phase of this Phase 2a study,” said Alain Rolland, PhD, chief operating officer of EHP, in a press release.
The trial’s Safety Review Committee, composed of one physician not linked with the study and its principal investigator, recommends it continue without changes, following the review of blinded safety data from all the patients in the study’s first two groups, according to EHP.
Data collected up to one month after the first dose showed EHP-101 was well tolerated, with no serious treatment-related side effects. Only mild related side effects were reported.
An analysis of its pharmacokinetics — the movement of a medicine into, through, and out of the body — over the 12-week treatment showed no signs of EHP-101 accumulating in the blood.
“We are pleased that the safety analysis of the first two cohorts of this Phase 2a study of EHP-101 in systemic sclerosis has confirmed a positive safety profile of the drug to date, consistent with the safety profile we observed in our large Phase 1 study,” Rolland said. “EHP-101’s mechanism of action offers the prospect of important therapeutic effects for patients.”
The main goal of the Phase 2 study (NCT04166552) is to assess the safety of EHP-101, a treatment candidate containing a man-made molecule derived from cannabidiol (CBD).
CBD is the main biologically active compound in the cannabis plant and has anti-inflammatory properties, but it lacks the ability to induce a “high.”
Additional goals include assessing the therapy’s preliminary effectiveness versus a placebo, as measured by a composite measure of lung function, skin thickening, physician and patient global assessment, and functional disability.
The first two groups, totaling 18 participants, received EHP-101 at a low dose (25 mg) once daily (group one) or twice daily (group two) for 12 weeks with four weeks of follow-up.
The two new groups will receive a high dose of EHP-101 once daily (group three) and twice daily (group four). A total of 48 patients will be dosed and treatment will be maintained for 24 weeks, following a protocol amendment approved by the U.S. Food and Drug Administration.
This expansion in patients and treatment length may let EHP-101 move directly into a Phase 3 clinical trial, without a Phase 2b trial first, according to the company.