Phase 1 Trial in Australia to Test Safety of Emerald’s Cannabidiol-based EHP-101  

The launch of a Phase 1 clinical study to test the safety of Emerald Health Pharmaceuticals’ EHP-101, a cannabidiol-based oral formulation, in healthy volunteers has been announced.

EHP-101 is a potential treatment for scleroderma and multiple sclerosis. The drug was designed to enhance the effectiveness of cannabidiol, the active ingredient of marijuana, and help curb neuroinflammation, control myelination of the central nervous system, and ease fibrosis or tissue scarring throughout the body.

The two-part, randomized study (ACTRN12618001390279p) will take place in Australia.

In the first part of the trial, the company hopes to enroll up to 64 healthy volunteers who will receive a single increasing dose of EHP-101 (between 0.91 and 200 mg) or a placebo. Depending on the drug’s tolerability profile, the second part of the study will include up to 40 volunteers who will receive increasing oral doses of EHP-101 or a placebo.

The goal is to determine EHP-101’s safety, tolerability, pharmacokinetics (how the body processes the drug), food safety, and mechanism of action in the body.

In a mouse model of scleroderma, EHP-101 has shown favorable results in preventing skin and tissue scarring.

“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,” Jim DeMesa, MD, chief executive officer of EHP, said in a press release.

“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,” DeMesa said.

Emerald expects to have preliminary data from these studies by mid-2019.

“Based on our recent pre-IND [Investigational New Drug] meeting with the [U.S. Food and Drug Administration], we believe the results from this Phase 1 study are likely to support Phase 2 studies in both MS and scleroderma,” DeMesa said.

The efficacy of EHP-101 will also be tested in multiple sclerosis because of the drug’s ability to influence myelination and neuroinflammation.

EHP-101 has already received orphan drug status in the United States by the FDA, and in Europe from the European Commission, as a potential treatment for scleroderma.