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Edesa Biotech Marks Enrollment Milestone in Dermatitis Study
TORONTO, ON / ACCESSWIRE / December 1, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"TORONTO, ON / ACCESSWIRE / December 1, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of more than 75% of the patients planned for 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.The double-blind, placebo-controlled study is evaluating the safety and efficacy of 2.0% EB01 cream in approximately 170 evaluable subjects in total. In addition to the primary cohort, the company is preparing to initiate the exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects. The company noted that telehealth options and expanded recruitment efforts have helped investigators reach new patient populations and bolster enrollment, despite pandemic-related disruptions.Due to physician and patient interest, the company has also added a voluntary open-label extension for study patients once they complete their treatment in the main study. This guarantees that participants in the placebo arm have access to treatment with the active ingredient. The open label extension is also designed to provide longer term usage data, since allergic contact dermatitis (ACD) often reoccurs, or is chronic.Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the pace of enrollment has increased since the company reported positive interim results this summer. \"Enrollment trends have been very encouraging, and we are turning our focus to rapidly completing the study and preparing for the next steps in the development of this potentially first-in-class drug technology.\"EB01 is an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory and...