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
'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
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 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.
Contact:
Tel: (805) 488-2800
Email: investors@edesabiotech.com
(C) 2023 Electronic News Publishing, source