Quoin Pharmaceuticals to Initiate Clinical Study for Peeling Skin Syndrome
August 06 2024 - 4:00AM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”) a clinical stage, specialty pharmaceutical company focused
on developing and commercializing novel treatments for rare and
orphan diseases, today announced the planned initiation of an
investigator-led clinical study in New Zealand to evaluate the
safety and efficacy of QRX003 in a pediatric patient with Peeling
Skin Syndrome (PSS). QRX003 is Quoin’s most advanced pipeline
product and is currently being evaluated in two late stage clinical
trials in the United States as a potential treatment for Netherton
Syndrome (NS). Both studies are being conducted under an open
Investigational New Drug (IND) application with the Food and Drug
Administration (FDA).
“We are excited to expand QRX003’s development into this second
indication, peeling skin syndrome, where it is believed the
mechanism of action of our product could also provide a benefit for
this devastating disease. Given the overlapping nature of how PSS
presents, patients with the disease are known to have been
previously misdiagnosed as having NS. Currently there are no
clinical studies listed for peeling skin syndrome on
clinicaltrials.gov as actively recruiting and dosing subjects and
there is no approved treatment or cure, presenting a further
opportunity for Quoin to achieve the first regulatory approval for
another rare genetic disease,” stated Michael Myers, CEO, Quoin
Pharmaceuticals. “The planned initiation of this study represents
the execution of a key pillar of Quoin’s strategy to expand the
clinical testing of QRX003 into other rare and orphan disease
indications and we are actively assessing additional opportunities
beyond this one.”
QRX003 is a unique “whole body, whole life” topical lotion that
targets the vicious circle of skin inflammation and barrier
disruption.
Quoin is conducting two ongoing clinical trials evaluating
QRX003 for the treatment of Netherton Syndrome. For more
information about the trials, please
visit: https://www.nethertonsyndromeclinicaltrials.com/.
About Peeling Skin Syndrome (PSS)
Generalized inflammatory peeling skin syndrome (PSS) is a rare
autosomal recessive genodermatosis caused by loss-of-function
disease-causing variants of the corneodesmosin gene (CDSN),
resulting in excessive shedding of the superficial layers of the
epidermis. Patients generally suffer from a variety of
conditions including severe pain and chronic pruritis (itch). There
is currently no approved treatment for PSS, and patients manage
symptoms using over-the-counter emollients.
About QRX003
QRX003 is a topical lotion, formulated with a proprietary
delivery technology, and contains a broad- spectrum serine protease
inhibitor, whose mechanism of action is intended to perform the
function of a specific protein, called LEKTI. The absence of LEKTI
in Netherton patients leads to excessive skin shedding resulting in
a highly porous and compromised skin barrier. QRX003 is designed to
lead to a more normalized skin shedding process and the formation
of a stronger and more effective skin barrier.
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. All statements that reflect the Company’s
expectations, assumptions, projections, beliefs, or opinions about
the future, other than statements of historical fact, are
forward-looking statements, including, without limitation,
statements relating to the Company’s expected cash runway, the
belief that the data set from both clinical studies could
potentially be sufficiently robust and comprehensive to support an
NDA filing, without the need for any additional clinical studies in
Netherton subjects, and the belief that certain protocol changes
has enhanced the potential for a successful outcome and Quoin’s
products in development 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. 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
including, but not limited to, the Company may need to raise
additional funds sooner than planned, the clinical studies may not
generate data which is sufficiently robust and comprehensive to
support an NDA filing and the Company’s ability to obtain
regulatory approvals. More detailed information about the risks and
uncertainties affecting the Company is summarized in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023 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. 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.com
Investor RelationsPCG AdvisoryJeff
Ramsonjramson@pcgadvisory.com(646) 863-6341
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