TORONTO, ON / ACCESSWIRE / July 30, 2020 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to initiate a study phase 2 / phase 3 clinical trial of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The company recently received accelerated approval to begin the Phase 2/3 study in Canada and is seeking government grants to expedite site selection and initiate patient recruitment.
EB05 is an investigational monoclonal antibody that the company claims may regulate the overactive immune response associated with acute respiratory distress syndrome (ARDS) – 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-CoV1 and Influenza viruses.
Based on previous clinical data and the mechanism of action, the company believes that modulating the TLR4 signaling pathway could reduce the number of patients in intensive care and decrease the need for mechanical ventilation, potentially saving lives. . The safety and tolerability of EB05 has been demonstrated in over 120 subjects. Antibody therapy has been shown to suppress fever as well as stabilize heart and respiratory rates in test subjects who were injected with a potent inducer of acute systemic inflammation.
“The submission of the IND for EB05 in COVID-19 patients marks a key milestone in our plans to expand our planned Phase 2/3 study,” said Dr Par Nijhawan, CEO of Edesa. “We have received positive interest from key opinion leaders regarding our proposed clinical trial and are communicating with hospitals across the country regarding our protocol. “
As planned, the phase 2/3 study of Edesa will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in hospitalized adult patients who have or are at risk of developing ARDS. The company plans to enroll up to 450 patients in the first phase of the trial. Patients will receive a single dose intravenous infusion of EB05 or placebo. If the drug treatment shows promising results when reading phase 2, the protocol allows for further recruitment as a pivotal phase 3 study. The newly filed IND application for the COVID-19 study completes and refers to an existing approved IND for EB05.
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 COVID-19 hospital patients develop ARDS, which rises to 67% to 85% for patients admitted to intensive care. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and the characteristics of the patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and damage to the lungs which 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 from high death rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke / chemical inhalation, sepsis, chest injury, and other causes. Before COVID-19, ARDS accounted for 10% of intensive care unit admissions, or more than 3 million patients worldwide each year. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths per 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 diseases with clearly unmet medical needs. Edesa’s flagship product candidate, EB01, is a novel nonsteroidal anti-inflammatory drug (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis that has shown statistically significant improvements in several clinical studies. The company is developing advanced monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a wide range of diseases, including infectious diseases associated with inflammation. Due to the global health emergency, Edesa has prioritized the development of EB05 as a potential treatment for moderate to severe COVID-19 patients. The company is headquartered in Markham, Ontario, Canada, with a US 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 can be identified by the use of words such as “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “may”, ” power ”,“ ”“ could ”,“ should ”,“ could ”,“ potential ”or“ continue ”and variations or similar expressions, including statements related to: the belief of the company that EB05 could regulate the response overactive immune response associated with ARDS, the company’s belief that EB05 may modulate the TLR4 signaling pathway for the benefit of patients, and the company’s plans for its Phase 2/3 study. Readers should not place undue reliance on these forward-looking statements, which are not guarantees 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 that may cause actual results or future events to differ materially from forward-looking statements. . These risks include: Edesa’s ability to obtain regulatory approval or successfully commercialize one 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 will not be effective against the diseases tested in its clinical trials, the risk that Edesa will not abide by the terms of the license with third parties and therefore loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, timing and success of submission, acceptance and approval 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 ability of the business to control or predict. For a discussion of other risks and uncertainties associated with Edesa’s business, please refer to Edesa’s public company reports filed with the United States 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. Unless required by law, Edesa assumes no obligation to update these statements.
Edesa Biotech, Inc.
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