Edesa Biotech Enrolls First Patient in COVID-19 Study

Rhea-AI Summary

Edesa Biotech, Inc. (NASDAQ:EDSA) has enrolled its first patient in a Phase 2/Phase 3 clinical trial for its investigational drug, EB05, aimed at treating hospitalized COVID-19 patients. EB05 is designed to moderate the immune response associated with Acute Respiratory Distress Syndrome (ARDS), which affects 20%-42% of hospitalized COVID-19 patients. The trial plans to include around 316 patients across approximately 40 hospitals. If successful, EB05 could provide crucial treatment options for severe cases of COVID-19.

Positive

• First patient enrolled in Phase 2/Phase 3 trial for EB05.
• EB05 targets ARDS, a major cause of mortality in COVID-19.
• Potential to enroll 316 patients across 40 hospitals.
• Previous data indicates potential effectiveness in reducing ICU admissions.
• The drug has shown safety in over 120 subjects.

Negative

• No guarantee of regulatory approval for EB05.
• No assurance that EB05 will demonstrate efficacy in clinical trials.

TORONTO, ON / ACCESSWIRE / November 30, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2/Phase3 clinical trial evaluating the company's investigational drug, EB05, as a therapy for hospitalized COVID-19 patients.

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.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that 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, Dr. Nijhawan believes that modulating the TLR4 signaling pathway could reduce the number of ICU patients and decrease the need for mechanical ventilation, ultimately saving lives.

"Initiating this study brings us one step closer to providing effective treatment options for patients facing some of the worst effects of the SARS-CoV2 infection. By preventing or treating ARDS, our drug candidate could help lessen concerns about COVID-19 by providing a treatment option even for the most serious patients," 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. The safety and tolerability of EB05 has been demonstrated in more than 120 subjects.

Blair Gordon, PhD, Vice President of Research and Development of Edesa, said that Edesa plans to enroll approximately 316 patients in the Phase 2 portion of the multicenter, double-blind, placebo-controlled study. The company expects to enroll up to approximately 40 hospitals in the study.

"We are excited to announce the first patient was dosed in Toronto, Ontario and we look forward to providing access to this promising therapy to patients across both Canada and the U.S.," said Dr. Gordon. "Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal 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 (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 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. ARDS has historically affected approximately 200,000 patients each year in the United States, resulting in nearly 75,000 deaths annually.

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. Edesa's lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated infectious diseases. Due to the global health emergency, Edesa has prioritized the development of EB05 as a potential treatment for hospitalized COVID-19 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 regulate the overactive immune response associated with ARDS, the company's belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, and the company's plans regarding its Phase 2/3 study. 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 Edesa Biotech's Phase 2/Phase 3 trial about?

The trial is evaluating the investigational drug EB05 for treating hospitalized COVID-19 patients, focusing on reducing the effects of Acute Respiratory Distress Syndrome (ARDS).

What does EB05 aim to achieve in COVID-19 treatment?

EB05 is intended to modulate the immune response to potentially lower ICU admissions and the need for mechanical ventilation in severe COVID-19 cases.

How many patients will be enrolled in the EB05 trial?

The trial plans to enroll approximately 316 patients across about 40 hospitals.

What is the significance of EB05 targeting ARDS?

Targeting ARDS is critical as it affects 20%-42% of hospitalized COVID-19 patients and is linked to high mortality rates.

What prior safety data is available for EB05?

EB05 has demonstrated safety and tolerability in more than 120 subjects in previous studies.