Edesa Biotech Marks Enrollment Milestone in Dermatitis Study

Rhea-AI Summary

Edesa Biotech, Inc. (NASDAQ:EDSA) has completed over 75% enrollment for its Phase 2b study of the EB01 cream for chronic allergic contact dermatitis, involving approximately 170 subjects. The company is also initiating a dose-ranging study for an additional 40 participants. A voluntary open-label extension allows placebo patients access to EB01 post-study. Interim results showed promising efficacy, with a 1.7-fold difference in primary endpoints and no serious adverse events reported. EB01 aims to provide a non-steroidal treatment alternative for ACD, addressing a significant unmet medical need.

Positive

• Over 75% enrollment achieved for Phase 2b study of EB01.
• Promising interim efficacy results reported, showing a 1.7-fold difference in primary efficacy endpoint.
• Open-label extension for placebo patients ensures access to treatment post-study.

Negative

• None.

TORONTO, ON / ACCESSWIRE / December 1, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has completed enrollment of more than 75% of the patients planned for the primary cohort of a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for chronic allergic contact dermatitis.

The double-blind, placebo-controlled 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 is preparing to initiate the exploratory, dose-ranging component of the study, which will separately evaluate lower-strength concentrations of EB01 in an additional 40 subjects. The company noted that telehealth options and expanded recruitment efforts have helped investigators reach new patient populations and bolster enrollment, despite pandemic-related disruptions.

Due to physician and patient interest, the company has also added a voluntary open-label extension for study patients once they complete their treatment in the main study. This guarantees that participants in the placebo arm have access to treatment with the active ingredient. The open label extension is also designed to provide longer term usage data, since allergic contact dermatitis (ACD) often reoccurs, or is chronic.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the pace of enrollment has increased since the company reported positive interim results this summer. "Enrollment trends have been very encouraging, and we are turning our focus to rapidly completing the study and preparing for the next steps in the development of this potentially first-in-class drug technology."

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.

"Developing a safe and effective alternative to steroids is especially important for ACD patients with chronic lesions and other debilitating symptoms, and we are pleased to be one step closer to a solution," said Dr. Nijhawan.

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.

About EB01

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. 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. 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 one 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. (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 belief that targeting the sPLA2 enzyme family with enzyme inhibitors will have a superior anti-inflammatory therapeutic effect; the company's intention to focus on rapidly completing the Phase 2b study of EB01 and preparing for the next steps in the development; the company's belief that EB01 could be potential first-in-class drug technology; 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.

Contacts:
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech, Inc.

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FAQ

What is the latest enrollment news for Edesa Biotech's EB01 study?

Edesa Biotech has completed over 75% enrollment for its Phase 2b clinical study of EB01 for chronic allergic contact dermatitis.

What are the interim results for Edesa Biotech's EB01?

Interim results indicated a 1.7-fold difference in primary efficacy endpoints compared to placebo, with no serious side effects reported.

What is the purpose of the open-label extension in Edesa Biotech's study?

The open-label extension allows patients who received placebo to access EB01 after the main study, gathering longer-term data on treatment.

How many subjects are involved in the EB01 clinical study?

The Phase 2b clinical study involves approximately 170 evaluable subjects.

What is EB01 and its significance in treatment for allergic contact dermatitis?

EB01 is a non-steroidal anti-inflammatory cream targeting chronic allergic contact dermatitis, aiming to provide a safer alternative to steroid treatments.