TORONTO, ON / ACCESSWIRE / July 13, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company has expanded patient enrollment to Canada for the final part of a Phase 2b study evaluating its EB01 drug candidate as a monotherapy for chronic Allergic Contact Dermatitis (Eczema), or ACD. The first part of the ACD study was conducted in the United States, where enrollment is ongoing.
ACD is one of the most common skin diseases. The Canadian Center for Occupational Health and Safety reports that ACD accounts for about 20% of all cases of occupational dermatitis. The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens, according to the agency.
Par Nijhawan, MD, Chief Executive Officer of Edesa, said that occupational dermatitis adversely impacts both employees and employers. "In addition to the debilitating symptoms for patients, it can be very difficult to identify or mitigate exposure when the allergen occurs in the workplace. Changes in work responsibilities or the substitution of materials is not always possible and many chronic ACD patients can end up on disability, resulting in lost income and disability claims," Dr. Nijhawan said. "Our hope with EB01 is to provide patients with meaningful symptom relief and get them back to work."
Edesa recently reported that EB01, a non-steroidal anti-inflammatory compound, met a key interim study parameter and an independent data monitoring board recommended that the company continue to enroll subjects in the study. The company plans to enroll up to at least 120 additional evaluable subjects, who will be provided with either Edesa's EB01 topical treatment (at a 2.0%, 1.0% or 0.2% concentration) or a placebo cream.
The study's primary outcome will be the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. A key secondary outcome will be the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment) scale. Due to physician and patient interest, the company is also adding an open-label extension for study patients.
Blair Gordon, PhD, Edesa's Vice President of Research and Development, said that making EB01 available at Canadian investigational sites is expected to accelerate the completion of enrollment. "I'm pleased to report that we have already randomized the first Canadian patients for the 28-day treatment."
Dr. Gordon noted that here are limited options for chronic ACD patients. "We believe that addressing the inflammation cascade at its inception represents a potentially innovative approach to treating ACD and other inflammatory diseases," he said. In two previous clinical studies, Edesa's EB01 drug candidate has demonstrated statistically significant improvement of multiple symptoms, including itching, scaling, rash and fissures.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company's two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts. Connect with us on Twitter and LinkedIn.
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 regarding its Phase 2b clinical study, including its expectation that making EB01 available at Canadian investigational sites can accelerate the completion of enrollment; and the company's belief that EB01 could potentially exert a powerful anti-inflammatory effect. 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, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. 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.
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SOURCE: Edesa Biotech