Edesa Biotech Reports Phase 2b Study Reaches Full Enrollment

• Primary Endpoint To Be Reached Within 30 Days, With Topline Data Available by End of Year
• Company Evaluating Partnership and Out-Licensing Opportunities Outside North America for Its First-in-Class, Anti-Inflammatory Drug Candidate

TORONTO, ON / ACCESSWIRE / September 7, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment has been completed for a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). EB01 represents a potentially new class of non-steroidal, anti-inflammatory treatment for this often-debilitating occupational disease.

All the remaining subjects are expected to complete the primary treatment period within the next 30 days, and Edesa anticipates that topline data will be available by the end of the year.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that encouraging interim data as well as the robust pace of enrollment are driving the company's excitement regarding the upcoming readout.

"We are pleased to have completed enrollment ahead of schedule, and we are especially grateful to the patients, physicians and research staff for enabling us to reach this important milestone. EB01 represents a potentially powerful new way to manage inflammation, even in severe cases, without the safety concerns and side effects of topical corticosteroids. This is especially important for patients with chronic lesions and inflammation," said Dr. Nijhawan.

Edesa reported that while topline and final study results are pending and subject to regulatory review, the company is advancing its commercialization strategy for its EB01 drug candidate. This includes preparing trial design and regulatory filings, prioritizing potential add-on or adjacent disease indications for future studies, and exploring potential commercialization partners.

"Outside our primary target markets in North America, we plan to evaluate strategic licensing or partnering arrangements with pharmaceutical companies for the further development or commercialization of EB01, such as in areas where a partner may contribute additional resources, infrastructure and expertise," Dr. Nijhawan said.

EB01 is a topical vanishing cream that contains a novel, 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 - 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. Due to physician and patient interest, the company also added a voluntary 90-day open-label extension with the 2% cream for study patients once they complete their treatment in the main study. The complete data package will be analyzed following the completion of the main study's primary and secondary endpoints as well as the open label extension.

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. No serious treatment-related adverse events were reported for either treatment group.

About Allergic Contact Dermatitis

Contact dermatitis, which can be either irritant contact dermatitis or ACD (sometimes called allergic contact eczema), 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 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 30 million people globally with allergic contact dermatitis, with approximately 5 million patients estimated to have chronic or reoccurring exposure to the causal allergen. To the company's knowledge, there are currently no treatment options specifically labelled for ACD.

About Edesa Biotech

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. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) - Phase 2b: Ongoing; Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. 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. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.

Edesa has completed enrollment for the final cohorts of patients in a double-blind, placebo-controlled confirmatory Phase 2b study evaluating the safety and efficacy of 2.0% EB01 topical cream. 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. At the interim analysis for the Phase 2b study, an independent data 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 the ISGA score relates to an improvement in signs and symptoms.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) - Phase 3: Enrolling

EB05 inhibits signaling through TLR4 - a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

EB05 has extensive preclinical and clinical experience, including evaluations in more than 600 hospitalized Covid-19 subjects. In an international Phase 2 study, a single dose of EB05 demonstrated compelling preliminary evidence of the drug's ability to reduce mortality in target patient populations. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Edesa is evaluating two study cohorts based on the World Health Organization Covid-19 Severity Index for the Phase 3 part of a Phase 2/3 clinical trial. The first cohort will assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus additional organ support (WHO Level 7). The primary endpoint for the Level 7 patients will be 28-day mortality. The second cohort is enrolling hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). The primary endpoint for the Level 6 patients will be the number of ventilator free days at 28 days.

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 forecast that all the remaining subjects should complete the primary treatment period within the next 30 days, with topline data available by the end of the year; the company's belief that EB01 represents a potentially powerful new way to manage inflammation, even in severe cases, without the safety concerns and side effects of topical corticosteroids; the company's plans to further develop its commercialization strategy, including plans for registration trial design, and related regulatory filings; the company's plans to evaluate strategic licensing or partnering arrangements with pharmaceutical companies for the further development or commercialization of EB01, such as in areas where a partner may contribute additional resources, infrastructure and expertise; the company's evaluation of EB01 potential utility for other inflammatory conditions; and the company's timing and plans regarding its clinical studies. 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.

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

SOURCE: Edesa Biotech, Inc.