Regulators Approve Updated Phase 3 Trial Design for Edesa Biotech’s ARDS Drug

TORONTO, ON / ACCESSWIRE / October 25, 2023 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that Health Canada has approved the company's proposal to harmonize clinical trial designs in the U.S. and Canada for an ongoing Phase 3 study of EB05 (paridiprubart). Edesa's monoclonal antibody is currently being evaluated as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related.

The harmonized protocol calls for treatment of approximately 600 ARDS subjects hospitalized with SARS-CoV2 infections who are on invasive mechanical ventilation, both with and without additional organ support such as extracorporeal membrane oxygenation (ECMO). The primary endpoint is the mortality rate at 28 days. The amended study design replaces the previous protocol which targeted a population of more than 800 subjects, with two independent cohorts and cohort-specific endpoints. Earlier this year, Edesa and the U.S. Food and Drug Administration agreed on the primary efficacy endpoint and single, smaller population for the Phase 3 study.

Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech said that having a single, harmonized protocol in the U.S. and Canada will facilitate enrollment, trial management and data analysis.

"We are pleased that regulators have agreed to our plans to optimize the study population and other protocol updates. We believe that aligning our efforts across the U.S. and Canada will streamline the development of EB05 and ultimately deliver a first-in-class therapy for critically ill ARDS patients who today continue to suffer from high rates of morbidity and mortality," said Dr. Nijhawan.

Paridiprubart is a first-in-class monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic (HDT) candidate inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated both by viruses, like SARS-CoV2 and influenza, as well as in the pathogenesis of chronic autoimmune diseases. In a Phase 2 clinical study that the company completed during the pandemic EB05 (paridiprubart) reduced mortality by 84% among critically ill patients with ARDS. A parallel in vitro study also demonstrated that paridiprubart inhibits inflammation from influenza and other pathogens.

Dr. Nijhawan said that the company is also exploring various approaches to evaluate EB05 in a general, all-cause ARDS population.

About 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 the pandemic, 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 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune 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 (daniluromer), 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 its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis (scleroderma), an autoimmune rheumatic disorder that causes fibrosis, (scarring/hardening) of skin and internal organs. 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 plans to harmonize its Phase 3 study protocol of EB05; the company's belief that having a single, harmonized protocol in the U.S. and Canada will facilitate enrollment, trial management and data analysis; the company's belief that aligning its efforts across the U.S. and Canada will streamline the development of EB05 and ultimately deliver effective therapy for critically ill ARDS patients who today continue to have few effective treatment options and suffer from high mortality rates; the company's plans to explore exploring various approaches to evaluate EB05 in a general ARDS population; 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. 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.
(289) 800-9600
investors@edesabiotech.com

SOURCE: Edesa Biotech