Edesa Biotech Adds Mechanically Ventilated Patients to Phase 3 ARDS Study

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TORONTO, ON / ACCESSWIRE / May 24, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company has initiated enrollment for a second cohort of patients for the Phase 3 part of a Phase 2/3 study of the company's critical care drug candidate, designated EB05.

Edesa is currently evaluating EB05, a monoclonal antibody, in critically ill patients with Covid-19-induced Acute Respiratory Distress Syndrome (ARDS), a severe respiratory illness that can result in long ICU stays and high mortality rates. The company's first study cohort is recruiting the most critically severe patients receiving mechanical ventilation plus additional organ support, including extracorporeal membrane oxygenation (ECMO) therapy, also known as Level 7 patients under the World Health Organization's Covid-19 Severity Scale. This new, second cohort is open to hospitalized patients on invasive mechanical ventilation alone (WHO Level 6 patients). Edesa's decision to include the second cohort followed a company review of drug product inventories of EB05.

"We are pleased to be in a position to expand the eligible patient population to include a broader spectrum of critically ill patients," said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. "This will allow ICU physicians in the critical care setting to utilize EB05 earlier in the treatment paradigm - before it may be needed as a potential rescue therapy - with the hope of further reducing the number of days in the ICU and preventing more deaths."

The primary endpoint for the Level 6 patients will be the number of ventilator free days at Day 28 following administration of a single intravenous infusion of EB05. Secondary endpoints will include ventilator free days at Day 60 as well as the mortality rate at Day 28 and Day 60. The protocol for the Level 6 cohort calls for approximately 500 evaluable subjects. As previously reported, the primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The protocol for the Level 7 patients calls for approximately 315 evaluable subjects.

The evaluation of EB05 in both the Level 6 and Level 7 patient populations was previously approved by regulators in Canada, Colombia and Poland. Edesa, however, prioritized the initiation of the most severe cohort first given the urgent medical need. Enrollment for both cohorts is now running in parallel, and results will be evaluated independently. The company is currently in discussions with regulators in the U.S. regarding the approval of the final Phase 3 design.

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

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. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Connect with us on Twitter and LinkedIn. Sign up for news alerts.

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.

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 contract dermatitis (ACD) - Phase 2b: Enrolling

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 is enrolling 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.

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 EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company's plans to expand the eligible patient population for the EB05 study to include the full spectrum of critically ill patients; the company's belief that its plans will allow ICU physicians in the critical care setting to utilize EB05 earlier in the treatment paradigm, with the hope of potentially further reducing the number of days in the ICU and preventing more deaths; the company's belief that EB05 could increase the number of ventilator free days and reduce mortalities in Level 6 and Level 7 patients; the ability of the company to enroll the required number of evaluable subjects in the study; the company's ability to receive approval for the Phase 3 study design in the U.S.; 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.

Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150

SOURCE: Edesa Biotech

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