Quoin Pharmaceuticals Announces Further Positive Clinical Data from Ongoing Pediatric Netherton Syndrome Study
January 14 2025 - 7:30AM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a clinical stage, specialty pharmaceutical company
focused on rare and orphan diseases, today announces positive
interim clinical data from its ongoing Investigator Pediatric
Netherton Syndrome clinical study.
The Investigator Pediatric Study continues to
demonstrate significant improvement in the skin area treated with
QRX003 versus the non-treated area. At the mid-point of the testing
period the Investigator’s Global Assessment (IGA) of the skin
condition improved from “Severe” at baseline to “Mild” after six
weeks of dosing twice a day with QRX003, indicating a very
substantial improvement in a short period of testing. As a result
of these positive results, the subject is being transitioned to
having QRX003 applied to their whole body surface area (BSA) as
opposed to the approximately 20% of their BSA that was being tested
for the initial 6 weeks.
In addition, there have been no adverse events
or safety concerns reported to date for this subject, which is
consistent with observations from each of Quoin’s ongoing clinical
studies in Netherton Syndrome subjects.
Quoin CEO, Dr. Michael Myers, said, “Earlier
this week we shared positive data from our ongoing open label
clinical study in subjects aged 14 years and older and provided
photographic evidence of the improvement in that subject’s skin,
which is accessible via this link. Today, we are very pleased to
announce another positive update from our pediatric study across a
number of clinical endpoints for the subject in this study. The
significant improvement in the Investigator’s Global Assessment
(IGA) from Severe at Baseline to Mild-Moderate after 12 days of
dosing, and now to Mild after 6 weeks of dosing is truly
remarkable, and we believe that the investigator’s decision to
transition the subject to “whole body” treatment is an exciting
step forward that will provide even more representative data on the
potential safety and efficacy of QRX003 in Netherton Syndrome
patients. We look forward to expanding this study to include
additional pediatric subjects in other countries, and we believe
each of these subjects may have an opportunity to move directly to
whole body testing based on the positive nature of the results
generated to date. With this study well underway and the adult
“whole body” study cleared to proceed by the FDA, we are beginning
to assemble what we hope will be very compelling clinical evidence
that supports the potential of QRX003 as a safe and effective
treatment for Netherton Syndrome patients.”
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 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 descriptions 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,” “hope,”
“plan,” “anticipate,” “look forward,” “believe,” “may,” 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 belief that the decision to transition
the pediatric subject to “whole body” treatment will provide even
more representative data on the safety and efficacy of QRX003 as a
treatment for Netherton Syndrome; expanding the study to include
other pediatric subjects in other countries, the belief that such
subjects may may have an opportunity to move directly to whole body
testing based on the results generated to date, beginning to
assemble what we hope will be very compelling clinical evidence
that supports the potential of QRX003 as a safe and effective
treatment for Netherton Syndrome patients 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; whether its
studies successfully generate data that is sufficiently robust and
comprehensive to support an NDA filing for QRXOO3 as an approved
treatment for Netherton Syndrome; 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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