Edesa Biotech Anti-Inflammatory Drug Candidate Assigned Name
TORONTO, ON / ACCESSWIRE / June 15, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced today the assignment of the name "daniluromer" for its first-in-class anti-inflammatory drug candidate.
Daniluromer is a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory effect since the compound acts at the inception of inflammatory cascades rather than after inflammation has occurred.
Earlier this year, Edesa reported favorable preliminary, topline results from a Phase 2b clinical study of a topical cream formulation of daniluromer (designated EB01) as a monotherapy for chronic moderate-to-severe allergic contact dermatitis (ACD). EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models.
"Daniluromer represents a potentially powerful new way to manage inflammation without the safety concerns and side effects of topical corticosteroids. This is especially important for patients with chronic inflammation," said Par Nijhawan, MD, Chief Executive Officer of Edesa.
Edesa expects daniluromer to be published in an upcoming World Health Organization (WHO) list of recommended international nonproprietary names. The WHO, under its International Nonproprietary Names (INN) Program, provides a globally recognized system for selecting unique names to identify pharmaceutically active substances. An approved generic name is a prerequisite to apply for a branded drug name and to market a drug.
About Edesa Biotech
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, 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 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 sPLA2 inhibitors could provide a powerful anti-inflammatory effect since they act at the inception of inflammatory cascades rather than after inflammation has occurred; the company's belief that daniluromer represents a potentially powerful new way to manage inflammation without the safety concerns and side effects of topical corticosteroids, especially for patients with chronic inflammation; the company's expectation that the name daniluromer will be published in an upcoming WHO list of recommended international nonproprietary names; 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.
CONTACT
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800
investors@edesabiotech.com
SOURCE: Edesa Biotech
View source version on accesswire.com:
https://www.accesswire.com/761371/Edesa-Biotech-Anti-Inflammatory-Drug-Candidate-Assigned-Name
