TORONTO, ON / ACCESSWIRE / March 22, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today that it has entered into a definitive license agreement under which the company, through a subsidiary, has acquired additional global rights to a non-steroidal anti-inflammatory technology that forms the basis of the company's EB01 and EB02 drug candidates.
The license agreement, with the technology's inventor, provides Edesa with development and commercialization rights to multiple patent families as well as know-how related to the underlying technology. Edesa previously licensed this drug technology from Hebrew University of Jerusalem for topical dermatology and certain gastrointestinal indications, and through this additional license agreement now holds exclusive global rights for all fields of use in humans and animals.
Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the move bolsters the company's strategic position on a key inflammatory pathway ahead of an upcoming clinical milestone. "This agreement significantly strengthens the breadth of our intellectual property position for a proprietary technology that we believe could have broad utility across multiple indications." He noted that the agreement was structured to minimize immediate cash outlays.
Edesa recently announced that it has completed enrollment of the first cohort of a Phase 2b clinical study evaluating EB01 as a monotherapy for chronic Allergic Contact Dermatitis (ACD), a potentially debilitating condition and occupational illness. The company plans to initiate a blinded interim analysis once all subjects in the first cohort complete the 28-day treatment. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in ACD patients.
EB01 contains a non-steroidal anti-inflammatory compound known as an sPLA2 (secretory phospholipase-2) inhibitor. When activated, sPLA2 enzymes have been shown to initiate a cascade of inflammatory lipid mediators along a well-known pathway that is currently the target of steroids and other anti-inflammatory drugs such as ibuprofen. 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.
About Allergic Contact Dermatitis
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company's knowledge there are currently no treatment options specifically labelled for ACD. Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.
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. EB01 employs a novel, non-steroidal mechanism of action and in two clinical studies has demonstrated statistically significant improvement of multiple symptoms in ACD 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 potential value, success and timing of clinical milestones; the company's belief that this license agreement could significantly strengthen its intellectual property position; the company's belief that the licensed technology could have broad utility across multiple indications; and the company's belief that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. 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 and the timing and success of submission, acceptance and approval of regulatory filings. 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.
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SOURCE: Edesa Biotech