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

TORONTO, June 20, 2019 /PRNewswire/ -- Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis.

The FDA "safe to proceed" letter formally approves the company's Phase 2b clinical protocol and authorizes the company to begin its clinical investigation. Edesa expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate.

EB01 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, like ibuprofen, the topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients.   

"There are limited options for ACD patients and we have been pleased with the level of interest from physicians in the U.S.," said Dr. Par Nijhawan, Chief Executive Officer of Edesa. "The company is committed to rapidly advancing our clinical plans and remains on track to initiate our clinical study for EB01."

In addition to its lead product candidate, Dr. Nijhawan noted that the company plans to selectively target additional indications within the areas of dermatology and gastroenterology. The company also plans to expand its portfolio with assets that can drive long-term growth opportunities.

"This is an active and exciting time for Edesa and we look forward to providing clinical and business updates over the coming quarter," said Dr. Nijhawan. 

Clinical Protocol for Phase 2b Trial of EB01
The protocol evaluates EB01 in a randomized, double-blind, vehicle-controlled, sample size adaptive design. ACD patients in this study will be treated for 28 days with various strengths of EB01 cream. Primary outcome measures will evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream. The company plans to complete an interim analysis following the enrollment of the first cohort to determine the total sample size in the second part of the study; up to 166 total patients may be enrolled. Additional details on the protocol are available on www.clinicaltrials.gov.

About Allergic Contact Dermatitis (ACD)
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States, and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.

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's investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. 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 Toronto, 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 commitment to rapidly advance its clinical plans and the company's plans to selectively target additional indications within the areas of dermatology and gastroenterology and expand its portfolio with assets that can drive long term growth opportunities. 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.  

SOURCE Edesa Biotech, Inc.