Quoin Pharmaceuticals Announces Opening of First Clinical Site for Netherton Syndrome Clinical Study
July 06 2022 - 8:30AM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a specialty pharmaceutical company focused on rare and
orphan diseases, announces that the first clinical site has now
been fully opened for its clinical study to evaluate QRX003 for the
treatment of the rare genetic disease, Netherton Syndrome. The
opening of additional sites is in process and patient recruitment
is expected to begin shortly.
This randomized, double blinded,
vehicle-controlled study is being conducted under a U.S.
Investigational New Drug (IND) Application and will assess two
different doses of QRX003 topical lotion versus a vehicle lotion in
Netherton patients. The test materials will be applied once daily
over a twelve-week period, to pre-designated areas of the patient’s
body. Based on discussions with the U.S. Food and Drug
Administration (FDA), a number of different clinical endpoints will
be assessed in the study.
The active ingredient in QRX003 is a broad
spectrum serine protease inhibitor, whose mechanism of action is
intended to down-regulate the hyperactivity of skin kallikreins
leading to a more normalized rate of skin shedding. If proven to be
safe and effective, long term daily application of QRX003 could
lead to the development of a more normally functioning skin barrier
and a significant improvement in the quality of life of Netherton
patients.
Quoin CEO, Dr. Michael Myers, said, “We are very
pleased to announce another significant milestone in the
development of QRX003 for this very underserved patient population.
The opening of this first clinical site, with full Institutional
Review Board approval, is testimony to the great work of our CRO,
Therapeutics Inc. With the opening of additional sites well
underway, we are poised to initiate patient recruitment
shortly.
“This is also an important step forward for our
partners with whom we have established supply and distribution
agreements for QRX003 in 60 countries, as it potentially advances
the path to approval in their territories. Furthermore, many of
these regions have early-access programs that the data from this
study could potentially enable QRX003 to participate in, and be
made available on a named patient basis prior to formal regulatory
approval.”
In conjunction with the company’s strategy of
self-commercializing its portfolio of products in the U.S. and
Europe, Quoin has established a global network of marketing
partnerships for QRX003 that will help support its mission of
ensuring that every patient, everywhere, can access Quoin’s
products, once approved.
About Quoin Pharmaceuticals Ltd.Quoin
Pharmaceuticals Ltd. is a clinical stage 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
four 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, Scleroderma, Epidermolysis Bullosa and others. For
more information, visit: www.quoinpharma.com or LinkedIn for
updates.
Cautionary Note Regarding Forward Looking
StatementsThe 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
April 14, 2022, 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.,
CEOmmyers@quoinpharma.comInvestor RelationsPCG AdvisoryStephanie
Princesprince@pcgadvisory.com(646) 863-6341
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