Quoin Pharmaceuticals Initiates Clinical Testing of Lead Product in Pediatric Netherton Syndrome Patient
November 05 2024 - 8:00AM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a clinical-stage
specialty pharmaceutical company focused on novel treatments for
rare and orphan diseases, today announced that it has initiated the
testing of the safety and efficacy of QRX003 in a young child with
Netherton Syndrome (NS), a rare inherited genetic disease. There is
currently no approved treatment for NS and no cure.
The clinical assessment is being led by Dr. Alan
Irvine, a consultant dermatologist at Children’s Health Ireland and
professor of dermatology at Trinity College Dublin. Dr. Irvine is
president of the International Eczema Council and an elected member
of the Royal Irish Academy. He has published over 250 peer-reviewed
papers in high-impact journals, including many on epithelial
genetics.
“We are pleased to announce this latest initiative
for Quoin as we strive to generate the broadest and most diverse
data set possible for QRX003 in Netherton Syndrome patients.
Furthermore, we are delighted that Professor Irvine, one of the
world’s leading researchers in this disease, has agreed to perform
this assessment of QRX003. Currently, we are testing patients aged
14 years and up in our two ongoing clinical studies and we hope
that data generated by Professor Irvine will facilitate lowering
the eligibility age further. In addition, we look forward to
broadening the scope of this clinical assessment to include three
additional pediatric subjects in Spain,” said Dr. Michael Myers,
Quoin CEO.
QRX003 is Quoin’s most advanced pipeline product
and is currently being evaluated in two late-stage clinical trials
as a potential treatment for NS under an open Investigational New
Drug application with the U.S. Food and Drug Administration.
Clinical data generated to date for QRX003 in NS patients has been
promising with all evaluable subjects demonstrating improvement
across a number of endpoints with no treatment-related adverse
events recorded. In addition to the five open clinical sites in the
United States, a sixth site is opening in Saudi Arabia. On October
22, Quoin also announced the planned opening of two additional
clinical sites in the United Kingdom, each of which has a cohort of
patients potentially eligible for recruitment.
About Netherton SyndromeNetherton
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 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 QRX003QRX003 is a topical
lotion formulated with a proprietary delivery technology that
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 promote
a more normalized skin-shedding process and the formation of a
stronger and more effective skin barrier.
For more information about Quoin’s current clinical
trials please visit:
https://www.nethertonsyndromeclinicaltrials.com/
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 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, go to: www.quoinpharma.com.
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. 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, -a second clinical site to open in Spain with
potentially three additional pediatric Netherton patients, the
Company striving to generate the broadest and most diverse data set
possible for QRX003 in Netherton Syndrome patients, the Company
hoping that data generated by Professor Irvine will facilitate the
Company lowering the eligibility age further, the Company opening a
sixth site in Saudi Arabia, a planned opening of two additional
clinical sites in the United Kingdom (each of which has a cohort of
patients potentially eligible for recruitment), and Quoin’s
products in development collectively having 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’s ability to deliver a
safe and effective treatment for Netherton Syndrome, the clinical
study may not be successful may not generate data which is
sufficiently robust and comprehensive to support lowering the
eligibility age further, the Company’s ability to open the planned
sites as and when planned and and other factors discussed 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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