- Delta variant contributes to rapid enrollment amid growing scientific rationale for targeting Toll-like Receptor 4 (TLR4)
- Blinded interim analysis from Phase 2/3 study expected in current quarter
TORONTO, ON / ACCESSWIRE / August 26, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate as a single-dose therapy for hospitalized COVID-19 patients.
As of August 25, 2021, Edesa reported that more than 525 subjects have been randomized into the study to be treated with either Edesa's monoclonal antibody (designated EB05) plus standard of care treatment, or placebo plus standard of care. Approximately 35 of these patients have been assigned to an investigation sub-study evaluating EB05 as a rescue therapy for patients with critically severe COVID-19 symptoms, including patients who have been ventilated for more than five days or are receiving extracorporeal membrane oxygenation (ECMO) therapy.
Additionally, the company reported that all patients planned for a key interim analysis have been randomized and completed the treatment protocol. Edesa expects the analysis from third-party statisticians to be completed in the coming weeks.
The company said that the interim analysis will include data from approximately 316 subjects. The blinded comparative interim analysis of treatment data and events is expected to inform patient segmentation and associated endpoints for the final part of study. As a Phase 2/3 study, enrollment has continued during the analysis.
Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, attributed the rapid pace of enrollment to the growing scientific rationale for targeting Toll-like Receptor 4 (TLR4), the attractiveness of the single-dose treatment, the broad potential utility for the drug candidate as well as increased disease incidence in regions where Edesa's clinical sites are located.
"We have continued to see rapid enrollment in our trial this summer, especially in the southern hemisphere. With the Delta variant causing another wave of infections in North America, we are now experiencing some of the highest weekly rates of enrollment since we initiated our study," said Dr. Nijhawan. "The prevalence of the Delta variant, as well as any future variants, underscores the urgent need for therapeutics that can address the mechanisms underlying the progression to severe disease and respiratory failure."
"We anticipate being in a position to provide the interim results for our Phase 2/3 study this quarter," said Dr. Nijhawan. "On behalf of Edesa, I'd like to express our continuing gratitude to the patients, their families and healthcare workers along with the clinical site teams for enabling us to reach these key milestones."
Dr. Blair Gordon, Edesa's Vice President of Research and Development, reported that with support from the federal government, the company has now established a network of 46 clinical sites at hospitals in Canada, Colombia and the United States.
"With all the planned clinical sites trained and up-and-running, and drug product on hand, our research and development team and study partners are preparing for an efficient transition into the anticipated Phase 3 study portion of the study," he said.
EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. 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. Prior to COVID-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.
Edesa's study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government. To date, the company has reached all clinical enrollment and project targets specified under the grant ahead of schedule.
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). 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.
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, and the company's timing and plans regarding its Phase 2/3 study, including the company's belief that it will be in a position to provide interim results for its Phase 2/3 study within the next three to four weeks. 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