Edesa Biotech Receives Approval from Health Canada for Clinical Study

Jennifer Schram Edesa Biotech, Main Page, Portfolio News, Press Release

Edesa Biotech Receives Approval to Begin 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 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. 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.”

– Dr. Par Nijhawan, Chief Executive Officer, Edesa Biotech Inc.

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.”

– Michael Brooks, President, Edesa Biotech Inc.

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 that, to its knowledge, none have been subjected to a formal review and/or approved by the FDA because they entered the market prior to 1962.

Related Article: Edesa Biotech Receives Approval to Proceed with U.S. Clinical Study

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant unmet medical needs. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plan to enroll up to 48 patients in the first stage of the trial and the company’s plans to transition from a proof of concept study to a Phase 2 study. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property and the timing and success of submission, acceptance, and approval of regulatory filings. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contacts

Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800
investors@edesabiotech.com