Emerald Health Pharmaceuticals Completes Enrollment of

SAN DIEGO, CA, Oct. 07, 2022 (GLOBE NEWSWIRE) — Emerald Health Pharmaceuticals Inc. (“EHP” or the “Company”), a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, has completed enrolling the first two cohorts of nine patients each of its Phase II clinical study of the Company’s lead product candidate, EHP-101, an oral formulation of a patented new molecule. This study is assessing the effectiveness of EHP-101 in treating patients suffering from systemic sclerosis (“SSc”). After completing drug dosing and monitoring for each patient as per the study protocol, EHP expects to report interim results from the study in early 2023.

This SSc Phase 2a trial is a double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with SSc. SSc is a disease characterized by rapid fibrosis in the skin and internal organs. There are no approved products for treatment.

In the first two cohorts of the Company’s SSC Phase 2a trial of 18 patients suffering from SSc, the Company is administering two doses to each patient, first once daily and then twice daily. The treatment lasts for 12 weeks, with a 4-week follow-up. Further details about the study design can be found on ClinicalTrials.gov: NCT04166552.

The Safety Review Committee overseeing the SSc Phase 2a clinical trial will meet in the fourth quarter of 2022 to assess the safety and pharmacokinetics data for the completed cohorts to determine whether to allow the clinical trial to progress to cohorts 3 and 4.

EHP submitted a protocol amendment to the FDA to increase the size of cohorts 3 and 4 from 18 to 48 subjects and to increase the treatment duration from 12 weeks to 24 weeks. The Company applied for this amendment to create a pathway to advance directly into a Phase 3 clinical trial of EHP-101 in patients suffering from SSc once the Phase 2a trial is…