Edesa Biotech, Inc. Marks Enrollment Milestone in Dermatitis Study
December 01, 2021 at 08:05 am EST
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Edesa Biotech, Inc. 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.
Edesa Biotech, Inc. is a Canada-based clinical-stage biopharmaceutical company developing various ways to treat inflammatory and immune-related diseases. The Companyâs advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. It is evaluating EB05 in a Phase III study as a potential treatment for acute respiratory distress syndrome (ARDS), a life-threatening form of respiratory failure. In addition, the Company is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic allergic contact dermatitis (ACD), a common occupational skin condition. It is conducting a Phase II trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. The Company is also developing product candidates for a number of chronic dermatological and inflammatory conditions.