First Step in Development Process of QRX003 for the EU
ASHBURN, Va., March 10, 2022 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a specialty pharmaceutical company focused on rare and orphan diseases, today announced that its wholly-owned subsidiary, Quoin Pharmaceuticals, Inc., has submitted a Scientific Advice Briefing Document with the European Medicines Agency (EMA) for QRX003, the Company’s investigational treatment for Netherton Syndrome, a rare and devastating genetic disease for which there is currently no available treatment or cure.
The briefing document is intended to solicit feedback and guidance on the clinical and regulatory pathway for advancing QRX003 into clinical testing and subsequent potential marketing authorization submission and commercialization in the EU.
“The submission of this briefing document is the first step in the formal development process of QRX003 as a potential treatment for Netherton Syndrome in the EU,” said Dr. Michael Myers, Chief Executive Officer of Quoin. “We look forward to receiving guidance from the EMA on the clinical and regulatory requirements to advance the development of the product in the EU. Quoin has previously received written guidance from the FDA on the clinical requirements for the US and key elements of that feedback have been incorporated into this submission to the EMA.”
About Netherton Syndrome
Netherton Syndrome, a form of Ichthyosis, is a rare, hereditary skin disorder caused by a mutation in the SPINK5 gene (serine protease inhibitor, Kazal Type 5) that leads to severe skin barrier defects and recurring infections, as well as a pronounced predisposition to allergies, asthma, and eczema. Patients also often suffer from severe dehydration, chronic skin inflammation and stunted growth.
Currently, there is no cure for Netherton Syndrome, nor are there any approved therapeutic treatments.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises three products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Epidermolysis Bullosa and others. For more information, go to: www.quoinpharma.com.
Cautionary Note Regarding Forward Looking Statements
The Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" included in the Company’s Annual Report on Form 20-F filed with the SEC on March 29, 2021 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Stephanie Prince
sprince@pcgadvisory.com
(646) 863-6341
