TORONTO, ON / ACCESSWIRE / October 21, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2b clinical trial evaluating the company's lead product candidate, EB01, as a monotherapy for patients with moderate to severe chronic allergic contact dermatitis (ACD). The U.S. Food and Drug Administration recently approved Edesa's clinical protocol and provided a "safe to proceed" letter, which formally authorized the company to begin its clinical investigation.
In the first cohort, ACD patients will be treated for 28 days with EB01 cream, an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. The adaptive-designed study will primarily evaluate the safety and efficacy of EB01 in ACD patients. Investigators will also evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream as secondary and exploratory measures. Edesa plans to perform a blinded interim analysis following the completion of the first cohort to determine the total number of patients for the second part of the study.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the initiation of the study has been a key company priority. "Initiating this study brings us one step closer to providing new options for patients with ACD, especially for those patients coping with side effects and limitations of current treatments," he said. "We believe that addressing the inflammation cascade at its inception represents a potentially innovative approach to treating ACD and other inflammatory diseases and we look forward to sharing our progress."
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. There are currently no treatment options specifically indicated for ACD.
Investigational centers for the EB01 study are located in Baton Rouge, LA; Bexley, OH; Chapel Hill, NC; Fridley, MN; Long Beach, CA; Louisville, KY; New York, NY; Plainfield, IN; and Washington, DC.
Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.
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 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 plans to perform a blinded interim analysis following the completion of the first cohort and its belief that the study brings it closer to providing new options for patients with ACD. 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.
Edesa Biotech, Inc.
SOURCE: Edesa Biotech, Inc.
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