Home Biotech News Edesa Biotech Receives Regulatory Approval to Initiate COVID-19 Study

Edesa Biotech Receives Regulatory Approval to Initiate COVID-19 Study


TORONTO, ON / ACCESSWIRE / June 15, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients. The company reported that it has EB05 drug product available now and is seeking government grants to accelerate the initiation and rollout of the study, beginning at up to 30 sites.

EB05 is a monoclonal antibody that has demonstrated the ability to suppress the release of proinflammatory cytokines that are often observed in severe COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling – a key component of the innate immune system and an important mediator of inflammation responsible for acute lung injury that has been shown to be activated during SARS and Influenza infection. Based on previous clinical data and the mechanism of action, the company believes that modulating this well understood signaling pathway could reduce the number of ICU patients and intubation/ventilation procedures, ultimately saving lives. The safety and tolerability of EB05 have been demonstrated previously in over 120 subjects.

As planned, Edesa’s Phase 2/3 study will be an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized patients with moderate to severe COVID-19. The company plans to enroll up to 355 patients in the first phase of the trial. Patients will be infused intravenously with EB05 or placebo. Should the drug treatment demonstrate promising results at the Phase 2 readout, the protocol allows for enrollment to continue as a pivotal Phase 3 study.

“Health Canada’s expedited review process and subsequent approval of our Clinical Trial Application represents a significant step in developing new drugs that can treat the underlying conditions induced by the SARS-CoV-2 infection,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “We greatly appreciate the actions being taken by the government to expedite COVID-19 applications and provide support for clinical studies.”

Dr. Nijhawan explained that COVID-19 patients often have inflammation and injury to the lungs as a result of an overactive immune response, sometimes described as a “cytokine storm.” Moderate to severe patients often progress to ARDS (acute respiratory distress syndrome), a life-threatening form of respiratory failure, and the leading cause of death in COVID-19 patients. Countering this cytokine storm in hospitalized COVID-19 patients has been a key area of interest among researchers. There are currently few meaningful treatments for ARDS, other than supplemental oxygen and mechanical ventilation.

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 infectious diseases. Due to the global health emergency, Edesa has prioritized the development these antibodies as potential treatments for moderate to severe COVID19 patients. The company is based in Markham, Ontario, Canada, with U.S. offices 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 plans to seek grant funding and initiate new clinical studies in COVID-19 patients. 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 ext. 150

SOURCE: Edesa Biotech


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