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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 non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. In addition to 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 after the first 46 subjects are treated to determine the total number of patients for the second part of the study.
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 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. 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.