Synthetic CBD Derivative Based Drug For Systemic Sclerosis Phase 2a Trial Enters Final Stage

Emerald Health Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, has received a positive safety review following a pre-specified interim analysis by the Safety review committee (“SRC”) of its phase 2a study of EHP-101 for systemic sclerosis (“SSc”). EHP-101 is an oral formulation of VCE-004.8, a multitarget synthetic CBD derivative. The SRC has recommended that the trial continue without modification. EHP expects to report interim results from the study in early 2023.

The SRC is comprised of two physicians, one independent and the other the principal investigator in the trial. The SRC evaluated the blinded safety data from all patients enrolled in cohorts 1 and 2 at least up to one month post first dose, at 25 mg daily and 25 mg twice daily, respectively. They determined that EHP-101 was well-tolerated, with no drug-related serious adverse events and only mild related adverse events reported. The pharmacokinetic analysis of plasma samples over the course of the 3-month treatment did not show apparent drug accumulation in patients’ blood.

This SSc phase 2a trial is a double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of EHP-101 in patients with SSc. SSc is a disease characterized by rapid fibrosis of the skin and internal organs. EHP has completed the first two cohorts, each with nine SSc patients, administering two doses either once daily or twice daily. The treatment lasted for 12 weeks, with a 4-week follow-up. Further details about the study design can be found on ClinicalTrials.gov: NCT04166552.

EHP has obtained clearance from the FDA to amend the study protocol to increase the size of the higher-dose cohorts 3 and 4 from a total of 18 to a total of 48 subjects and increase the treatment duration from 12 weeks to 24 weeks. The company applied for this amendment to create a pathway to possibly advance directly into a phase 3 clinical trial of EHP-101 in patients suffering from SSc once the phase 2a trial is completed, rather than first conducting a phase 2b before continuing to a phase 3 trial.

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