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Edesa Biotech Marks Milestone in Enrollment

Edesa Biotech Inc., a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that the primary cohort of a Phase 2b clinical study evaluating the company’s drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis has enrolled more than 75% of the patients planned. The approximately 170 evaluable individuals in the double-blind, placebo-controlled study are investigating the safety and efficacy of 2.0 percent EB01 cream.

In addition to the primary cohort, the business is getting ready to start the exploratory, dose-ranging phase of the trial, which will look at lower-strength EB01 concentrations in an additional 40 people. Despite pandemic-related disruptions, scientists were able to reach additional patient populations and increase enrollment through telemedicine options and enhanced recruitment efforts, according to the business.

The company has also included a voluntary open-label extension for study patients once they have completed their therapy in the primary study due to physician and patient interest. This ensures that individuals in the placebo arm receive access to active ingredient treatment. Because allergic contact dermatitis (ACD) frequently recurs or is chronic, the open label extension is also intended to give longer-term usage data. Since the company achieved strong interim results this summer, Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, indicated that the speed of enrolment has risen.

Enrollment patterns have been very positive, so we’re focusing on finishing the trial as quickly as possible and getting ready for the next steps in the development of this potentially first-in-class therapeutic technology. Though the study’s Data and Safety Monitoring Board was masked to treatment assignment, the key effectiveness endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29, showed a roughly 1.7-fold difference between the treatment arms.

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