Edesa Biotech Expands COVID-19 Clinical Study to Colombia

Rhea-AI Summary

Edesa Biotech (NASDAQ:EDSA) has secured approval from Colombia's Ministry of Health to expand its clinical trial for the investigational drug EB05 in hospitalized COVID-19 patients. The trial, already underway in the U.S. and Canada, aims to evaluate EB05's efficacy in modulating immune response associated with Acute Respiratory Distress Syndrome (ARDS). About 316 patients will be enrolled across various sites in Colombia, with results expected to facilitate a subsequent Phase 3 study. This initiative demonstrates Edesa's commitment to address significant unmet needs in COVID-19 treatment.

Positive

• Approval received from Colombia's Ministry of Health to expand clinical trials for EB05.
• Enrollment of approximately 316 patients in the Phase 2 portion of the study.
• EB05 aims to reduce ICU admissions and the need for mechanical ventilation.

Negative

• None.

TORONTO, ON / ACCESSWIRE / January 11, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from the Ministry of Health (INVIMA) in Colombia to expand the clinical trial of its investigational drug EB05 in hospitalized COVID-19 patients. The study was previously approved in the U.S. and Canada, where enrollment is ongoing. The company reported that it has enlisted the support of a local research organization and will begin activating hospital sites in Bogota, Medellín, Bucaramanga, and other major metropolitan centers.

EB05 is a clinical-stage monoclonal antibody that Edesa believes 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 drug is delivered intravenously in a single infusion to hospitalized COVID-19 patients.

EB05 is intended to fill a critical gap in combatting the pandemic - alongside anti-viral treatments and vaccines under development by others. Based on previous clinical data and the mechanism of action, the company believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said the investigative sites in Colombia are among the best in Latin America, with well-established programs adhering to Good Clinical Practices and other internationally accepted standards, and the company looks forward to joining other pharmaceutical companies in extending innovative treatments to nations in Latin America.

"We greatly appreciate the actions being taken by the Colombian government to review and approve our clinical study. Collaborating with physicians and hospitals in Colombia allows us to complete this important study more quickly and reaffirms our commitment to provide broad access to a promising experimental treatment to people around the world," said Dr. Nijhawan.

Edesa's drug works by directly inhibiting a pattern recognition receptor called toll-like receptor 4 (TLR4), which has been shown to mediate inflammation as a result of infection by SARS-CoV2 and other respiratory infections, such as influenza. Recent third-party studies have demonstrated that severe COVID-19 patients frequently display elevated levels of certain damage-associated molecule patterns (DAMPs) that activate TLR4. Edesa believes targeting this key innate signaling pathway with EB05 could potentially disrupt the overactive and self-amplifying network of downstream proinflammatory cytokines, and thereby, reduce morbidity and mortality in hospitalized COVID-19 patients. The antibody therapy has previously demonstrated an ability to resolve fever as well as stabilize heart rates and breathing rates in test subjects who were injected with a potent inducer of acute systemic inflammation.

Edesa's international Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Edesa plans to enroll approximately 316 patients in the Phase 2 portion of the study. Data from the Colombian, Canadian and U.S. sites will be aggregated and analyzed together. Should the drug treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a 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 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 the patient population, according to the CDS. 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) in COVID-19 patients. 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. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD 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 modulate the TLR4 signaling pathway for the benefit of patients, and that by expanding the study to Colombia, the company can complete the Phase 2/3 study more quickly. 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's EB05 clinical trial in Colombia?

The trial aims to evaluate the efficacy and safety of EB05 in treating hospitalized COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS).

How many patients will be enrolled in the EB05 trial?

Approximately 316 patients are expected to be enrolled in the Phase 2 portion of Edesa's clinical trial.

What are the expected outcomes of the EB05 trial?

The trial seeks to demonstrate that EB05 can reduce ICU admissions and the need for mechanical ventilation in COVID-19 patients.

Where are the trial sites located for the EB05 study?

The trial will take place in major Colombian cities such as Bogotá, Medellín, and Bucaramanga.

When did Edesa receive approval for the trial expansion?

Edesa received approval from the Colombian Ministry of Health on January 11, 2021.