The WHO and USAN Adopt Generic Name for Edesa's ARDS Drug Candidate
Edesa Biotech, Inc. (NASDAQ:EDSA) has announced that the World Health Organization (WHO) has adopted the international nonproprietary name "paridiprubart" for its monoclonal antibody candidate, EB05. This drug is currently in a Phase 3 study targeting hospitalized Covid-19 patients suffering from Acute Respiratory Distress Syndrome (ARDS). The drug exhibited an 84% reduction in mortality risk compared to a placebo during Phase 2 trials. The assignment of a generic name is seen as a vital step for Edesa's future marketing and regulatory filings, as paridiprubart is one of the first drugs to utilize WHO's new nomenclature system for monoclonal antibodies.
- WHO adopted the generic name "paridiprubart" for EB05, enhancing its marketability.
- EB05 demonstrated an 84% reduction in the mortality risk of hospitalized Covid-19 patients during Phase 2 trials.
- Paridiprubart has received Fast Track designation from the FDA, facilitating expedited development.
- None.
- International name assignment is a key step in Edesa's development and commercialization plans
TORONTO, ON / ACCESSWIRE / April 4, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced the World Health Organization (WHO) has adopted the international nonproprietary name "paridiprubart" for the company's monoclonal antibody candidate, EB05. Paridiprubart (EB05) is currently being evaluated in an international Phase 3 study in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure.
The WHO, under its International Nonproprietary Names (INN) Program, provides a globally recognized system for selecting unique names to identify pharmaceutically active substances. A nonproprietary name is also known as a generic name. The generic name for EB05, pronounced "par-i-di-proo-bart" is one of the first group of drugs utilizing the WHO's new nomenclature system for monoclonal antibodies, which is based on antibody type and mechanism of action. The United States Adopted Name (USAN) Council has also adopted the same generic name for Edesa's EB05 monoclonal antibody.
"The assignment of the nonproprietary name for EB05 is an important step as we continue to advance this potential ARDS treatment toward study completion and regulatory filings," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "This allows us have a globally recognized name in place for future potential publications, labeling and marketing materials."
Paridiprubart has received Fast Track designation from the U.S. Food and Drug Administration following favorable Phase 2 results, which demonstrated significant evidence of the drug's ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given paridiprubart (EB05) plus standard of care treatment had an
About Paridiprubart
Paridiprubart (EB05) is a first-in-class monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immunity responses. The drug 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 paridiprubart (EB05), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immunity 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, a common occupational and work-related skin condition. Recently, the company 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. 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 international name assignment is a key step in Edesa's development and commercialization plans; the company's plans to advance paridiprubart as a potential ARDS treatment; the company's plans to complete the study completion and future, related regulatory filings; the company's belief that the INN assignment will allow it to have a globally recognized name in place for future potential publications, labeling and marketing materials; the company's believe that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; 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 ext. 150
investors@edesabiotech.com
SOURCE: Edesa Biotech
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FAQ
What is the significance of the name "paridiprubart" for Edesa's drug candidate EB05?
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