Edesa Biotech Receives Approval to Initiate COVID-19 Study in the U.S.

Rhea-AI Summary

Edesa Biotech (NASDAQ:EDSA) has received FDA clearance to commence the Phase 2 portion of its Phase 2/3 clinical study for EB05, an investigational drug targeting hospitalized COVID-19 patients. The study aims to evaluate the efficacy and safety of EB05 in adults at risk of developing Acute Respiratory Distress Syndrome (ARDS). With the goal of reducing ICU admissions and mortality, Edesa is initiating site processes in U.S. hospitals. The Phase 2/3 study is randomized and double-blind, with hopes to progress to a pivotal Phase 3 trial based on Phase 2 results.

Positive

• FDA clearance to begin Phase 2 study of EB05 for COVID-19.
• Potential of EB05 to inhibit key proinflammatory pathways linked to severe disease effects.
• Initiation of clinical trial sites in U.S. hospitals.

Negative

• None.

TORONTO, ON / ACCESSWIRE / October 19, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The Phase 2/3 study protocol has previously been approved by Health Canada. The company has begun the site initiation process at U.S. hospitals.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company is committed to rapidly getting EB05 into the hands of physicians on the front line of the pandemic. "Our EB05 study has been deemed safe to proceed by the FDA, marking another milestone in our plans to begin patient enrollment. We believe our drug candidate has the potential to inhibit a key proinflammatory pathway linked to some of the worst effects of the disease."

EB05 is an experimental monoclonal antibody that Edesa believes could 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. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of ICU patients and intubation/ventilation procedures, and ultimately saving lives.

As planned, Edesa's Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients who have or are at risk of developing ARDS. 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.

Hospitals interested in participating in the study should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475)

About ARDS
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. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.

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. Edesa's lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated infectious diseases. 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 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 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.

CONTACT:
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

View source version on accesswire.com:
https://www.accesswire.com/610873/Edesa-Biotech-Receives-Approval-to-Initiate-COVID-19-Study-in-the-US

FAQ

What is Edesa Biotech's Phase 2 study about?

Edesa Biotech's Phase 2 study involves the investigational drug EB05 for treating hospitalized COVID-19 patients, aiming to assess its efficacy and safety.

What does EB05 aim to treat?

EB05 aims to regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients.

What does FDA clearance for EB05 mean for Edesa Biotech?

FDA clearance signifies Edesa's ability to advance its clinical study for EB05, potentially leading to effective treatment options for COVID-19 patients.

What is the significance of the Phase 2/3 study for Edesa Biotech?

The Phase 2/3 study is significant as it evaluates EB05's effectiveness in reducing ICU admissions and mortality among COVID-19 patients, which could impact Edesa's future growth.