Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a clinical stage, specialty pharmaceutical company
focused on rare and orphan diseases, today announces additional
positive interim clinical data from one of its ongoing Netherton
Syndrome clinical studies.
In December 2024, Quoin announced positive data
from the first subject dosed twice-daily in Quoin’s ongoing
open-label study after 6-weeks of dosing with QRX003, marking the
midpoint of testing. The Company is now pleased to share clinical
data for that subject upon completion of testing. The following
table illustrates the clear improvements observed for this subject
from baseline through 12 weeks of twice-daily dosing with QRX003
across all measured clinical endpoints.
Table 1: First Patient Data from Open Label
Study Part B- Dosed Twice Daily with QRX003
End Point |
Baseline |
6 weeks |
12 weeks |
M-IASI* |
18 |
4 |
3 |
WINRS** |
7 |
4 |
2 |
IGA*** |
Moderate |
Mild |
Almost Clear |
*M-IASI: Modified Ichthyosis
Area of Severity Index, a score used to assess the severity and
extent of skin symptoms associated with ichthyosis. Lower scores
indicate improvement.**WINRS: Worst Itch Numeric
Rating Scale, which measures the severity of itch on an 11-point
scale (0 = no itch, 10 = worst imaginable
itch).***IGA: Investigator’s Global Assessment,
which uses descriptive categories (e.g., clear, mild, moderate,
severe) to evaluate the overall severity of Netherton Syndrome
symptoms.
Photographs illustrating the improvements in the
subject’s skin appearance can be accessed via the link below and
are available on Quoin’s
website.https://quoinpharma.com/pipeline/#trials
In addition, the patient satisfaction scores
across multiple assessed metrics which were highly positive after 6
weeks of testing demonstrated even further improvement after 12
weeks. No safety concerns were reported for the subject throughout
the study.
Quoin CEO, Dr. Michael Myers, said, “We are very
excited to announce continued positive results from our ongoing
Netherton Syndrome clinical studies. With the availability of
photographic evidence that clearly demonstrates the profound change
in skin appearance for this subject in our open-label study, we
believe we are continuing to develop a growing body of evidence of
the potential efficacy of QRX003 in Netherton Syndrome. The marked
improvement demonstrated across all measured endpoints is highly
encouraging. Furthermore, and importantly, the patient satisfaction
scores with QRX003 continue to be very positive, with no safety
concerns observed.
We are eagerly awaiting the initiation of our
‘whole body’ clinical study, which will be conducted by Dr. Amy
Paller at Northwestern University. We previously announced FDA
clearance to proceed with this study under an open Investigational
New Drug (IND) application in December and anticipate that clinical
data from this study will become a key component of the data
package we are assembling to support a New Drug Application (NDA)
filing for QRX003 as potentially the first approved treatment for
Netherton Syndrome. 2025 is already off to an exciting start for
Quoin and we look forward to providing additional updates
throughout the year.”
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 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, - potential efficacy of QRX003 as a treatment for
Netherton Syndrome, await the initiation of our ‘whole body’
clinical study, which will be conducted by Dr. Amy Paller at
Northwestern University, anticipate that clinical data from the
whole body study will become a key component of the data package
the Company is assembling to support a New Drug Application (NDA)
filing for QRX003 as potentially the first approved treatment for
Netherton Syndrome,), 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,
its studies may not be successful or may not generate data which is
sufficiently robust and comprehensive to 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
Quoin Pharmaceuticals (NASDAQ:QNRX)
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