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Edesa Biotech Receives Approval to Initiate Clinical Study in Patients with Hemorrhoids
TORONTO, ON / ACCESSWIRE / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"TORONTO, ON / ACCESSWIRE / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from Health Canada to begin a clinical study of its investigational drug, EB02, which the company is developing as a potential treatment for patients with grade I-III internal hemorrhoids.Health Canada reviewed Edesa’s clinical trial application and approved it by issuing a \"no objection letter,\" a standard guidance document that allows the company to proceed with its planned study. The exploratory study is designed to assess the safety and efficacy of EB02 among hemorrhoid patients at leading clinical research sites in Canada. The company plans to enroll up to 48 patients in the first stage of the trial. Should the initial results be encouraging, the company plans to transition from a proof of concept study to a Phase 2 study.“Health Canada's approval to begin clinical trials represents a significant milestone in our goal of demonstrating the broad potential of our novel non-steroidal anti-inflammatory technology,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “Based on our analysis of clinical data in dermatitis, there’s good reason to believe that EB02 may be effective in treating the erythema, swelling and exudation associated with hemorrhoids.”Formulated as a topical cream, EB02 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, the treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. The molecule has demonstrated highly selective, antagonistic activity against the secretory enzyme family involved in inflammation, pruritus and fibrosis.“Despite the high prevalence of this condition, patients have limited treatment options available to them. This product candidate represents a potential novel treatment for an indication where there has been little to no innovation,” said Michael Brooks, President of Edesa.Based on National Institutes of Health reports, hemorrhoids affect approximately 12.5 million adults in the U.S., or approximately 5% of the U.S. adult population; almost half of individuals 50 years and older experience symptomatic hemorrhoids. While there are commonly used products, the company noted...