TORONTO, ON / ACCESSWIRE / June 18, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of the company's COVID-19 drug candidate, and based on blinded comparative data, has recommended that the company's international study continue as planned.
The safety monitoring board, composed of independent subject matter experts, conducted a pre-planned interim review of the first patient cohort participating in Edesa's Phase 2/3 clinical study evaluating the company's EB05 drug candidate as a single-dose treatment for hospitalized COVID-19 patients. The DSMB assessed treatment data for safety and futility. After completing their analysis, the DSMB recommended that enrollment in the trial continue.
"The DSMB's recommendation that the trial continue is consistent with our expectation and the previous safety and tolerability profile of EB05," said Dr. Par Nijhawan, Chief Executive Officer of Edesa. "While it is not possible yet to draw conclusions, we are encouraged by the monitoring board's findings as well as the robust enrollment we have achieved to date."
Dr. Nijhawan said that Edesa is evaluating opportunities to expedite the timeline for completing the remaining part of the study and building a single robust dataset. As of June 16, 2021, more than 370 subjects in the U.S., Canada and Colombia have been enrolled in the Phase 2/3 study. The company plans to perform the next interim analysis on 316 evaluable subjects once treatment is completed and subject data is validated and aggregated.
The company recently filed a trial amendment with the Food and Drug Administration to streamline the U.S. protocol and align it with other jurisdictions. Following the exploratory analysis, the company also plans to adjust its current patient segmentation and associated endpoints, and maintain blinded data through the end of Phase 3.
"These planned changes could significantly reduce the number of additional patients enrolled in the study and could put us in the position to demonstrate results sooner," said Blair Gordon, PhD, Edesa Vice President of Research and Development.
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. 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.
JSS Medical Research is acting as Edesa's contract research organization for the international Phase 2/3 study. Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact [email protected] or visit www.clinicaltrials.gov (Identifier: NCT04401475).
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; the company's timing and plans regarding its Phase 2/3 study; the company's plans to adjust its current patient segmentation and associated endpoints, and maintain blinded data through the end of Phase 3; and the company's believe that such planned changes could significantly reduce the number of additional patients enrolled in the study and demonstrate results sooner. 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