TORONTO, ON / ACCESSWIRE / January 26, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.
Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that physicians involved in the company's ARDS study identified a number of COVID-19 patients who they believed could benefit from the experimental treatment, but were too ill to be considered for the main study. "This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure," Dr. Nijhawan said.
Edesa's sub-study is expected to enroll up to 100 ICU patients with severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy. The sub-study does not impact the design or results of Edesa's ongoing international Phase 2/3 study.
EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with ARDS. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling - an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of patients admitted to Intensive Care Units (ICU) and intubation/ventilation procedures, and ultimately saving lives.
Edesa's Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the Phase 2 part of the trial in Canada, the United States and Colombia. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.
Edesa's Vice President of Research and Development, Blair Gordon, PhD. said that data from the international sites will be aggregated and analyzed together. The sub-study, which is identical to the main study except for the patient enrollment criteria, will be analyzed separately. "The consistency of the study design across geographic regions and patient groups will allow us to efficiently evaluate the utility of the EB05 across a broad spectrum of hospitalized patients."
Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that 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. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients. 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. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.
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 immune response associated with ARDS, the company's belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, the company's believe that the sub-study could expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure, and the company's plans regarding its Phase 2/3 study. 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
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