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Edesa Biotech and FDA Agree on Primary Endpoint for Phase 3 ARDS Drug Study

  • 28-day survival will be evaluated in ARDS patients hospitalized with Covid-19
  • Updated protocol approved by study's ethics committee
  • Company exploring pathways for treating general ARDS patients

TORONTO, ON / ACCESSWIRE / March 15, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today reported that the company and the U.S. Food and Drug Administration (FDA) have agreed on the primary endpoint and population for a pivotal Phase 3 study evaluating Edesa's monoclonal antibody candidate, EB05, as a therapy for hospitalized patients with a severe form of respiratory failure. The FDA recently granted the program Fast Track designation.

Edesa believes that its investigational drug regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS), a severe respiratory illness that can result in long ICU stays and high mortality rates. The agreement announced today follows favorable Phase 2 results, which demonstrated compelling 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 an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

Under the amended protocol design, Edesa will evaluate a single cohort of severely ill patients on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation (ECMO). Edesa plans to enroll approximately 600 evaluable hospitalized subjects. The primary endpoint will be the mortality rate at 28 days. The number of ventilator free days at 28 days and mortality at 60 days will also be measured as key secondary endpoints.

"We are pleased with the outcome of our discussions with the FDA. Based on the strength of the preliminary data submitted, the FDA proposed using a 28-day mortality endpoint for the Phase 3 study," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "This was our preferred efficacy endpoint and a significant milestone in the development of our lead product candidate. We are now one significant step closer to completing our study and providing effective treatment options for severely ill patients."

Dr. Nijhawan said that the amended U.S. protocol has been approved by the study's independent ethics committee (formally known as the Institutional Review Board, or IRB). The company reported that recruitment at U.S. hospital sites has been initiated and will scale up in the upcoming quarters as investigational sites complete training on the amended protocol.

"This amended protocol provides an efficient design to facilitate recruitment and a clearer pathway to conducting a study in general ARDS since the updated protocol is not tied directly to treatment modalities defined by the World Health Organization Covid-19 Severity Scale," said Dr. Nijhawan.

He noted that since EB05 is designed to target the patient's own immune response (independent of the infectious agent), the investigational therapy could potentially have broad application across multiple disease indications, including ARDS caused by influenza and other potentially deadly pathogens. The company is currently exploring various approaches to evaluating EB05 in a general ARDS population.

About EB05
EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling, which has been shown to be activated by SARS-CoV-2, SARS-CoV-1 and Influenza viruses.

About Acute Respiratory Distress Syndrome (ARDS)
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 developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is EB05, a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immunity responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01, as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company has also received regulatory approval to conduct a Phase 2 trial for its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. 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 its investigational drug regulates the overactive and dysfunctional immune response associated with ARDS; the company's plans to evaluate a single cohort approximately 600 evaluable subjects; the company's belief in the strength of the rationale and analysis behind its study design; the company's belief that EB05 could have broad application across multiple disease indications, including ARDS caused by influenza and other pathogens; the company's belief that the amended protocol provides an efficient design to facilitate recruitment and clearer pathway to conducting study in general ARDS since the updated protocol is not tied directly to Covid-19 treatment modalities; the company's belief that the news announced today represents a significant milestone in the development of its lead product candidate, and that the company is now one significant step closer to completing its EB05 study and providing effective treatment options for severally ill patients; 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.

Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800

SOURCE: Edesa Biotech

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