Edesa Biotech Extends COVID-19 Clinical Study to Poland

Rhea-AI Summary

Edesa Biotech (NASDAQ:EDSA) has received approval from Polish regulators to expand its clinical trial for EB05, a monoclonal antibody candidate for treating hospitalized COVID-19 patients. This follows promising Phase 2 results, showing a 68.5% reduction in mortality risk among critically ill patients. The ongoing Phase 2/3 trial is also recruiting in the U.S., Canada, and Colombia, particularly focusing on patients needing advanced respiratory support. The company aims to update its Phase 3 protocol and explore expedited regulatory paths in multiple jurisdictions.

Positive

• Approval received from Polish regulators for EB05 clinical trial.
• EB05 demonstrated a 68.5% reduction in death risk in critically ill COVID-19 patients.
• Focus on severely affected patients using ECMO and invasive mechanical ventilation.
• International Phase 2/3 study expands to a new region with high COVID-19 cases.

Negative

• None.

• Expansion to European Union country follows favorable Phase 2 results
• Company focusing on critically ill hospitalized patients

TORONTO, ON / ACCESSWIRE / November 4, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that Polish regulators have approved a clinical trial application for the investigational use of the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients. Enrollment in the Phase 2/3 drug trial is ongoing in the U.S., Canada and Colombia.

Edesa believes that EB05 could regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The company recently reported that critically ill hospitalized patients given EB05 plus standard of care treatment had a 68.5% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Due to the lack of treatments available to patients with severe respiratory distress, the company has reported that it will focus enrollment for the Phase 3 portion of its international study on patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV) plus organ support.

"We urgently need effective therapies for patients once they become hospitalized, especially for ARDS patients who have failed all other drugs and treatment modalities. Given the profound effect that EB05 has demonstrated in reducing death in the most critically ill patient population, we are looking forward to expanding the study to Poland where daily COVID-19 case counts are high and on the rise," said Par Nijhawan, MD, Chief Executive Officer of Edesa.

Dr. Nijhawan reported that Edesa has enlisted the support of a local research organization and will begin activating hospital sites in major metropolitan areas.

Edesa's international Phase 2/3 study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. The company is currently filing amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol based on Phase 2 results, and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review and conditional approval programs in the U.S., Canada and other jurisdictions.

About EB05
EB05 is a monoclonal antibody developed to inhibit 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. In September 2021, Edesa announced positive results from the Phase 2 portion of its international Phase 2/3 study of EB05. The company reported that independent monitoring board concluded that "a clinically important efficacy signal" was detected and that the study "met its objective." The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial.

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.

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 the company is 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. Connect with us on Twitter and LinkedIn.

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 and dysfunctional immune response associated with ARDS; the company's belief in the broad potential utility and potential life-saving impact of its EB05 monoclonal antibody candidate; the company's plans to activate hospitals in Poland; the company's plans to file amendments with regulators to update the Phase 3 protocol and set targeted enrollment; and the company's timing and plans regarding its clinical studies in general. 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.

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

SOURCE: Edesa Biotech

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FAQ

What is the purpose of Edesa Biotech's clinical trial in Poland?

The trial aims to investigate the efficacy of EB05, a monoclonal antibody, in hospitalized COVID-19 patients, specifically those with Acute Respiratory Distress Syndrome.

What were the results of the Phase 2 trial for EB05?

The Phase 2 trial showed that EB05 resulted in a 68.5% reduction in the risk of death for critically ill hospitalized COVID-19 patients compared to placebo.

What steps is Edesa Biotech taking after the Phase 2 trial results?

Edesa is updating its Phase 3 protocol and expanding the trial's enrollment to include Poland while also considering expedited regulatory approvals.

How does EB05 work in treating COVID-19?

EB05 is designed to inhibit toll-like receptor 4 (TLR4) signaling, which is related to excessive inflammation and lung injury in COVID-19 patients.

What is the significance of Edesa's focus on ECMO and IMV patients?

These patients represent a critically ill population with few effective treatment options, making the study of EB05 particularly relevant.