Edesa Biotech Reports Enrollment Milestone in Phase 3 ARDS Study

Rhea-AI Summary

Edesa Biotech (NASDAQ:EDSA) announced a Phase 3 enrollment milestone for its monoclonal antibody candidate, EB05, targeting critically ill Covid-19 patients. Over 25% of subjects have been randomized, following positive Phase 2 results showing a 68.5% reduction in mortality risk. The study aims to confirm the efficacy and safety of EB05, especially for patients on ECMO and IMV+. The primary endpoint is 28-day mortality among approximately 315 patients, with additional metrics like ventilator-free days assessed. The company is also in discussions with the FDA regarding protocol amendments.

Positive

• Enrollment of over 25% completed in the Phase 3 study.
• Phase 2 results showed a 68.5% reduction in mortality risk.
• Potential for EB05 to address overactive immune responses in ARDS.

Negative

• None.

TORONTO, ON / ACCESSWIRE / February 17, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today provided an update on the Phase 3 part of a Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose therapy for hospitalized Covid-19 patients.

Edesa reported that more than 25% of the subjects have been randomized to date under the Phase 3 protocol design approved by Health Canada. The enrollment milestone follows favorable Phase 2 results, which demonstrated compelling preliminary evidence of EB05's ability to reduce mortality in the sickest patients. Among the results, critically ill hospitalized Covid-19 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.

Dr. Par Nijhawan, MD, Chief Executive Officer of Edesa, said that as SARS-CoV2 continues to evolve and becomes endemic there's an urgent need for therapeutics, like EB05, that are agnostic to variants. "Since EB05 is designed to target the patient's own immune response rather than the virus itself, we believe it has broad potential application for Covid and beyond," he said.

"We greatly appreciate the extraordinary efforts of the clinical teams and research staff who have been supporting the EB05 study," said Dr. Nijhawan. "Based on the significant effect demonstrated in reducing mortality in the Phase 2 study, we believe that Edesa's monoclonal antibody EB05 could significantly reduce mortalities and alleviate the stress on the healthcare system, especially in the ICU where beds are limited, care is very expensive and patient outcomes have been tragically poor."

EB05 was developed to regulate the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure that accounts for ~10% of all ICU admissions (pre-pandemic) and is the leading cause of death among Covid-19 patients. Specifically, EB05 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. In September 2021, the company reported that an independent monitoring board for the Phase 2/3 study concluded that "a clinically important efficacy signal" was detected. The monitoring board further recommended continuation of the study into a Phase 3 confirmatory trial. Edesa's Phase 2 study of EB05 in hospitalized Covid-19 patients was funded in part by a C$14 million grant from the Canadian Government's Strategic Innovation Fund.

The Phase 3 double-blind study is designed to assess the efficacy and safety of EB05 among critically ill COVID-19 patients receiving extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation plus organ support (IMV+), defined as Level 7 on the World Health Organization's COVID-19 Severity Scale. The primary endpoint for the Level 7 patients will be 28-day mortality. Ventilator free days and 60-day mortality will also be measured among other secondary endpoints. The amended trial protocol design calls for approximately 315 evaluable subjects. Edesa has filed similar protocol amendments with the U.S. Food and Drug Administration (FDA) as well as other jurisdictions. In the U.S., the company is currently in discussions with the FDA on the design of the final Phase 3 protocol.

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 prevents the lungs from oxygenating blood and ultimately 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. 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 life-saving impact of its EB05 monoclonal antibody candidate; the company's belief that there's an urgent need for therapeutics that are agnostic to SARS-CoV2 variants; the company's belief that EB05 could significantly reduce mortalities and alleviate the stress on the healthcare system; 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.

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

SOURCE: Edesa Biotech

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FAQ

What is the latest update on Edesa Biotech's Phase 3 clinical study for EB05?

Edesa Biotech reported that over 25% of subjects have been enrolled in the Phase 3 study for EB05, which is a single-dose therapy for hospitalized Covid-19 patients.

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

The Phase 2 study demonstrated a 68.5% reduction in the risk of dying among critically ill hospitalized Covid-19 patients treated with EB05 compared to the placebo.

What are the primary endpoints of the Phase 3 study for EB05?

The primary endpoint is 28-day mortality among patients receiving ECMO and IMV+ treatments, along with secondary endpoints like ventilator-free days.

How is Edesa Biotech preparing for FDA interactions regarding EB05?

Edesa is currently engaged in discussions with the FDA on the design of the final Phase 3 protocol and has filed similar protocol amendments.

What therapeutic area does EB05 target?

EB05 is designed to regulate the dysfunctional immune response related to Acute Respiratory Distress Syndrome (ARDS), which is the leading cause of death among Covid-19 patients.