Edesa Biotech Reports Positive Interim Results in Dermatitis Trial
June 03, 2021 at 07:38 am EDT
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Edesa Biotech, Inc. announced that the company's drug candidate EB01 has met a key interim study parameter. The company has now passed the initial inflection point of its Phase2b study and will continue enrolling the final cohort of patients. Edesa reported that interim study data from the first cohort met statistical thresholds previously approved by the U.S. Food and Drug Administration as part of an adaptive Phase 2b trial evaluating EB01 as a monotherapy for moderate to severe chronic Allergic Contact Dermatitis (ACD). Though blinded to treatment assignment, the study's Data and Safety Monitoring Board (DSMB) reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. Likewise, the DSMB reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment), a key secondary efficacy endpoint. Success on the ISGA is defined as a two-point reduction from baseline and a final ISGA score of '0' or '1' indicating clear or almost clear skin, respectively. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group. Based on these findings, the DSMB has recommended progression to the second cohort of patients. Interim study data is preliminary and full study results are subject to change; and since the analysis remains blinded, it is not possible to definitively conclude if EB01 may be outperforming placebo or vice versa. The initial cohort analyzed consisted of a population of 46 subjects, of whom 36 completed the study follow-up and were used in the interim analysis. As of June 2, 2021, 66 total patients (including the first cohort) have been randomized in the Phase 2b study.
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.
EDESA BIOTECH, INC. 
