• Positive Findings Support Potential Expanded Uses for Paridiprubart

TORONTO, ON / ACCESSWIRE / June 28, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced positive findings from an in vitro study of its monoclonal antibody candidate, paridiprubart, against a panel of respiratory pathogens. The study was completed by the University of Toronto in parallel to the company's ongoing clinical study of EB05 (paridiprubart) in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs. Approximately 10% of all ICU admissions are ARDS related.

The research results available today in preprint demonstrated that multiple pathogens, including Influenza A, coronavirus and a common bacterium (H. influenzae), can initiate an overactive immune response through Toll-like Receptor 4 (TLR4), a key component of the innate immune system. More importantly, the study determined that inflammation signaling from each of these pathogens was inhibited by Edesa's TLR4 antagonist, paridiprubart.

Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are designed to work across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks.

"The inflammatory pathways associated with ARDS and paridiprubart's mechanism of action are well understood and these latest findings - in combination with clinical experience in more than 600 subjects - provide further support for our view that our drug candidate could provide a safe and effective treatment for ARDS caused by coronaviruses, pandemic influenza and harmful bacteria," said Par Nijhawan, MD, Chief Executive Officer of Edesa. He noted that in addition to the pathogens tested in this research, a number of other viral glycoproteins directly bind and activate TLR4, including those from Ebola virus, dengue virus, and respiratory syncytial virus (RSV).

"We are encouraged by the University of Toronto data and the fact that damage response signaling through the TLR receptor appears to play a center role in the pathology of many of these lethal pathogens," said Dr. Nijhawan. "Because they are threat-agnostic, HDTs like paridiprubart have the potential to become standard of care in ICUs and critical countermeasures for both pandemic preparedness and biodefense."

The in vitro study was conducted in collaboration with the Toronto High Containment Facility at the University of Toronto under a grant from the Government of Canada's Strategic Innovation Fund. A preprint manuscript, titled Paridiprubart inhibits TLR4-dependant NF-κB activation by multiple pathogens is published at bioRxiv.org: https://www.biorxiv.org/content/10.1101/2023.06.27.545921v1.

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 Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About EB05 (paridiprubart)

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, SARS-CoV1 and Influenza, as well as in the pathogenesis of chronic autoimmune diseases.

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 of 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 such as the lungs, heart and kidneys. 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 the positive findings from the in vitro preclinical study in combination with previous clinical experience support potential expanded uses for paridiprubart; the company's belief that paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that may provide utility across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks; the company's view that paridiprubart could provide a safe and effective treatment for ARDS caused by coronaviruses, pandemic influenza and harmful bacteria; the company's belief that HDTs like paridiprubart have the potential to become standard of care in ICUs and critical countermeasures for both pandemic preparedness and biodefense; and plans and timelines regarding the company's 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.

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