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Edesa Biotech Reports Positive Healthy Volunteer Data and Expands Phase 2b Dermatitis Study to Patients with Facial Lesions
TORONTO, ON / ACCESSWIRE / December 3, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported that the company's
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"TORONTO, ON / ACCESSWIRE / December 3, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported that the company's lead product candidate, EB01, has demonstrated positive safety data in healthy volunteers participating in its ongoing Phase 2b clinical study in chronic allergic contact dermatitis (ACD), a debilitating disease that is frequently caused by allergens present in the workplace.The healthy volunteer cohort at the outset of Edesa's study is designed to clear the way for using the experimental topical treatment on the face of ACD patients. Due to the high prevalence of symptoms on the face of ACD patients, the expansion of the study to facial symptoms is expected to address a key aspect of the disease, while broadening the potential patient population.Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the face and hands are the most common body parts presenting with ACD because they are typically more open to contact with allergens. \"Symptoms on the face have a powerful impact on patients' quality of life and can be especially problematic for chronic ACD patients. The lesions are highly visible and difficult to treat with steroids due to concerns about skin thinning, dyspigmentation, abnormal hair growth and other common side effects of continuous steroid use.\"The data from the healthy volunteers were consistent with safety data from five previous clinical studies that demonstrated no serious adverse events or discontinuations due to adverse events. Since previous studies were focused solely on symptoms on the hands and arms, the company included the healthy volunteer cohort as a precautionary measure.Edesa Vice President of Research and Development, Blair Gordon, PhD reported that the healthy volunteers were treated with EB01 cream on one side of the face, while the placebo cream was applied to the other side of the face twice daily for one week. \"We are very pleased to see that none of the patients reported burning, stinging or itch associated with either the drug product or the placebo cream. No adverse events attributable to either treatment were observed. These results reaffirm the safety profile of our sPLA2 inhibitor technology and EB01,\" said Dr. Gordon.ACD patients participating in the study are being treated for 28 days with EB01 cream, which contains a...