Completion of enrollment is anticipated by calendar fourth quarter for the Phase 2b study of Edesa's potentially first-in-class, anti-inflammatory drug
TORONTO, ON / ACCESSWIRE / April 28, 2022 / Edesa Biotech, Inc. /zigman2/quotes/200172674/composite EDSA -2.63% , a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment for a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis (ACD) has been enrolling ahead of schedule.
Based on the current pace of recruitment, which had previously been impacted by pandemic-related shutdowns, the company anticipates completing enrollment of all 210 planned subjects by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023. The company noted that interest in the novel mechanism of action and positive interim data have helped bolster enrollment.
"As patients return to work and re-enter social circles, there's both an increase in potential exposure to the causal allergens and a greater desire to treat the inflammation," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "EB01 is being developed as a safe and effective alternative to steroids. This is especially important for ACD patients with chronic lesions, which are often on the hands and face and problematic to treat long-term with steroids."
Dr. Nijhawan noted that while study results will be data-driven, and are subject to regulatory review, the company is preparing to be in position to rapidly move forward. "We are preparing for the next steps in the advancement of this novel drug candidate toward commercialization, including registration trial design, regulatory filings, price modeling and potential regional partnering."
EB01 is an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids. 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 and allergic conditions.
The double-blind, placebo-controlled confirmatory study is evaluating the safety and efficacy of 2.0% EB01 cream in approximately 170 evaluable subjects in total. In addition to the primary cohort, the company has included an exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects.
The company previously reported that EB01 met key interim parameters in the ongoing Phase 2b study. Though blinded to treatment assignment, the study's Data and Safety Monitoring Board reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29. The monitoring board also reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment), a key secondary efficacy endpoint. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group.
EB01 is a topical vanishing cream containing a novel, non-steroidal anti-inflammatory compound. EB01 exerts its anti-inflammatory activity through the inhibition of certain pro-inflammatory enzymes known as secretory phospholipase 2, or sPLA2. These enzymes are secreted by immune cells upon their activation and produce arachidonic acid via phospholipid hydrolysis, which, in turn, initiates a broad inflammatory cascade. The sPLA2 enzyme family plays a key role in initiating inflammation associated with many diseases, and the company believes that targeting the sPLA2 enzyme family with enzyme inhibitors will have a superior anti-inflammatory therapeutic effect because the inflammatory process will be inhibited at its inception rather than after inflammation has occurred.
About Allergic Contact Dermatitis
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. 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. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with scientific literature pointing to a potentially larger undiagnosed population. More than 1 million patients are estimated to have chronic ACD. To the company's knowledge there are currently no treatment options specifically labelled for ACD.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. /zigman2/quotes/200172674/composite EDSA -2.63% 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 belief that targeting the sPLA2 enzyme family with enzyme inhibitors will have a superior anti-inflammatory therapeutic effect; the company's belief that enrollment Phase 2b study of EB01 can be completed by the fourth calendar quarter of 2022, with initial topline data available as early as the first calendar quarter of 2023; the company's belief that EB01 is potentially a first-in-class drug technology; the company's preparations to be in position to rapidly move forward, including regulatory filings, registration trial design, price modeling and potential regional partnering; and the company's timing and plans regarding its clinical studies, in general. 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.
(805) 488-2800 ext. 150
SOURCE: Edesa Biotech
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