First Groups Enrolled in Trial of EHP-101 for Systemic Scleroderma

Enrollment underway for groups 3 and 4 in study of cannabidiol-derived therapy

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The first two groups of patients have been enrolled in a Phase 2a clinical trial that’s testing the cannabidiol-derived medication EHP-101 in people with systemic scleroderma (SSc), the therapy’s developer Emerald Health Pharmaceuticals (EHP) announced.

Interim results are expected next year, according to EHP. Participants are currently being recruited for the third and fourth groups at locations in Australia, New Zealand, and the U.S., including Puerto Rico.

“We are pleased to reach the halfway point of EHP’s first Phase 2 trial, and doing so in SSc, a disease with no effective treatments,” Alain Rolland, PhD, chief operating officer of EHP, said in a press release. “We look forward to evaluating the interim analysis of the first two cohorts of this Phase 2 trial in early 2023.”

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The main goal of the Phase 2 study (NCT04166552) is to assess the safety of EHP-101, an experimental medicine containing a synthetic molecule derived from cannabidiol (CBD). CBD is a molecule found in the cannabis plant that isn’t psychoactive, meaning it doesn’t induce a “high,” but it has other biological properties, including notable anti-inflammatory effects. Regulatory authorities in the U.S. and Canada have ruled EHP-101 is not a controlled substance.

“EHP-101’s mechanism of action is first-in-class and offers the prospect of important therapeutic effects for patients,” Rolland said.

The first two groups in the study include 18 people with SSc. EHP is administering two doses to each patient, first once daily and then twice daily, for 12 weeks with four weeks of follow-up.

An independent committee tasked with monitoring the safety of participants will meet later this year and decide if the trial should continue with a third and fourth group.

These groups were originally intended to include 18 patients also, but EHP submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) asking they be expanded to 48 patients and the treatment duration lengthened from 12 to 24 weeks. If the results are positive, this would let EHP progress directly into a Phase 3 clinical trial to test the medicine’s effectiveness, rather than have to first do a separate Phase 2b trial to further test its safety.

The FDA did not respond to the amendment request with a mandated 30-day period, which, according to the administration’s review protocol, means EHP is allowed to make these changes.