· *Mortality reductions demonstrated across multiple patient groups*
· *Additional efficacy signals recorded in a broad range of mild to severe ARDS patients*
· *Company to focus on critically ill population for Phase 3*
*TORONTO, ON / ACCESSWIRE / October 19, 2021 / *Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced additional results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients.
The Phase 2 data were preemptively unblinded last month by the study's Data and Safety Monitoring Board (DSMB) due to a clinically important efficacy signal detected among the most critically ill patients. Since then, the analysis of the results has continued in other patient groups. Edesa believes EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients.
Edesa reported today that EB05 demonstrated mortality reductions in multiple patient groups beyond the initial findings, which showed that critically ill hospitalized patients treated with EB05 + Standard of Care treatment (SOC) had a 68.5% reduction in the risk of dying when compared to placebo + SOC at 28 days. Additional efficacy signals have also been identified.
Among the findings, the DSMB noted another mortality benefit in 136 hospitalized COVID-19 patients receiving supplemental oxygen (28-day mortality rate of 8.2% (5/61) in the EB05 + SOC arm versus 12.0% (9/75) in the placebo + SOC arm, Hazard Ratio (HR): 1.52 placebo vs. EB05, n=136). Within this group, a strong signal for patients with severe ARDS at baseline (based on the Berlin score) was investigated by the DSMB and was part of their decision to unblind the study. Consistent with the signal previously reported in critically ill patients, the DSMB concluded that the severe ARDS patients receiving supplemental oxygen at baseline had "a clinically important efficacy signal" with a 28-day mortality rate of 16.7% (2/12) in the EB05 + SOC arm versus 42.9% (6/14) in the placebo + SOC arm. Survival Analysis using Cox's Proportional Hazard Model in this group showed that the subjects treated with EB05 + SOC had a 66.0% reduction in the risk of dying when compared to placebo + SOC at 28 days (HR: 2.94 placebo vs. EB05; 95% CI: 0.59-14.60; p=0.19).
There were confirmatory efficacy signals detected in other groups including the 190 patients with mild to moderate ARDS at baseline (28-day mortality rate of 7.8% (7/90) in the EB05 + SOC arm versus 11.0% (11/100) in the placebo + SOC arm, HR: 1.46 placebo vs. EB05, n=190). Within this group, patients with mild to moderate ARDS receiving oxygen support beyond supplemental oxygen demonstrated a 50.7% reduction in the risk of dying in the EB05 + SOC arm compared to placebo + SOC at 28 days (HR: 2.03 placebo vs. EB05; 95% CI: 0.61-6.74; p=0.25). The 28-day mortality rate was 10.8% (4/37) in the EB05 + SOC arm versus 20.5% (8/39) in the placebo + SOC arm. In this group, patients treated with EB05 + SOC also had an increase of approximately 6.1 days alive and free of invasive mechanical ventilation (IMV) at 28 days versus those treated with placebo + SOC (p<0.05).
"We are excited about the potential utility of our monoclonal antibody given the profound effect that it demonstrated in reducing death in the most critically ill patient population. These results further strengthen our hypothesis and our belief in the potential life-saving impact of this drug," said Par Nijhawan, MD, Chief Executive Officer of Edesa.
Due to the lack of treatments available to critically ill patients and the clinically meaningful impact observed with respect to 28-day mortality, the company has decided to focus on this patient segment for the Phase 3 portion of the study. Edesa may also advance other subgroups of patients into Phase 3 at a later time.
Michael Brooks, PhD, President of Edesa, said that this approach could substantially reduce the number of additional patients needed for the Phase 3 study and put the company in the position to potentially file for its first marketing authorization application sooner than anticipated.
"The Phase 2 part of the study met its primary objective of identifying efficacy signals among the various patient stratifications. We are excited to see supportive efficacy signals across multiple patient segments. We plan to continue forward into the Phase 3 study prioritizing critically ill patients and are evaluating the most efficient way to utilize the existing dataset to support future regulatory filings, trials and applications," said Dr. Brooks.
Edesa plans to file amendments with regulators in the United States, Canada and Colombia to update the Phase 3 protocol and set targeted enrollment. Edesa is also evaluating opportunities to apply for expedited regulatory review programs in the U.S., Canada and other jurisdictions. The company plans to provide additional updates regarding its clinical activities and regulatory filings as they become available.
*Summary of Efficacy Signals*
The following table is a summary of the key signals detected in the Phase 2 patient population:
*Sub-Group Baseline Characteristics*
*Number of Subjects (N)*
Mild to Severe
Patients on ECMO and/or IMV with additional organ support
*28-day mortality:* 14.3% (2/14) for EB05 + SOC vs. 36.8% (7/19) for placebo + SOC; Hazard Ratio: 3.17 placebo vs. EB05; 95% CI: 0.66-15.35; p=0.15. Odds Ratio: 3.50 placebo vs. EB05; 95% CI: 0.60-20.41; p=0.16.
Patients on supplemental oxygenation
*28-day mortality:* 16.7% (2/12) for EB05 + SOC vs. 42.9% (6/14) for placebo + SOC; Hazard Ratio: 2.94 placebo vs. EB05; 95% CI: 0.59-14.60; p=0.19. Odds Ratio: 3.75 placebo vs. EB05; 95% CI: 0.59-23.87; p=0.16.
Mild to Moderate
Patients receiving high flow Oxygen Delivery or Non-invasive ventilation, ECMO and/or IMV with or without additional organ support
*28-day mortality:* 10.8% (4/37) for EB05 + SOC vs. 20.5% (8/39) for placebo + SOC; Hazard Ratio: 2.03 placebo vs. EB05; 95% CI: 0.61-6.74; p=0.25. Odds Ratio: 2.13 placebo vs. EB05; 95% CI: 0.58-7.79; p=0.25.
*Mean difference in days alive and free of IMV at 28 days:* 6.1 days more for patients treated with EB05 + SOC; p<0.05
Berlin ARDS Criteria: Mild = PaO2/FiO2 between 200 and 300 mm Hg; Moderate = PaO2/FiO2 between 100 and 200 mm Hg; Severe = PaO2/FiO2 under 100 mm Hg.
EB05 is an experimental monoclonal antibody that Edesa believes regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome (ARDS). ARDS is the leading cause of death in COVID-19 patients. Specifically, the drug 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. Edesa's study of EB05 in hospitalized COVID-19 patients is being funded in part by a C$14 million grant from the Canadian Government.
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 prevents the lungs from oxygenating blood. 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 .
JSS Medical Research (www.jssresearch.com) was the company's contract research organization for the study and conducted the data analyses.
*Cautionary Note Regarding Clinical Studies*
The company plans to analyze the topline data along with additional information gathered during this study, including safety and other outcome measures. Such analysis may result in additional, different or inconsistent findings to those included in this release. As such, investors should not rely on topline or Phase 2 (interim) results reported in this release as the final, definitive results of the Phase 2/3 study.
*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 use of EB05 to treat hospitalized COVID-19 patients; the company's belief in the broad potential utility and potential life-saving impact of its EB05 monoclonal antibody candidate; the potential to advance additional subgroups of patients into Phase 3 at a later time; the company's belief that its clinical strategy could substantially reduce the number of additional patients needed for the Phase 3 study and put the company in the position to potentially file for its first marketing authorization application sooner than anticipated; 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.
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
*SOURCE:* Edesa Biotech
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· *Mortality reductions demonstrated across multiple patient groups*