Quoin Pharmaceuticals Announces Further Clinical Evidence of QRX003 Effectiveness in Netherton Syndrome
2025年1月23日 - 10:30PM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a clinical stage, specialty pharmaceutical company
focused on rare and orphan diseases, today announces further
clinical evidence of the potential efficacy of QRX003 in Netherton
Syndrome.
In December 2024 and January 2025, Quoin
announced positive data from the mid-point and at completion of 12
weeks of testing the first subject dosed twice-daily in Quoin’s
ongoing open-label study which demonstrated evidence of clear
improvement across all measured clinical endpoints. Today Quoin is
sharing additional data on that subject at 4 weeks
post-discontinuation of treatment with QRX003. As the table below
illustrates all of the positive clinical benefits observed after 12
weeks of testing with QRX003 were completely reversed by 4 weeks
after discontinuation of treatment resulting in the subject’s
disease state reverting to the baseline status observed prior to
QRX003 treatment. These results strongly indicate that ongoing,
chronic treatment with QRX003 is necessary for a continued positive
clinical outcome in Netherton Syndrome patients.
Table 1: First Patient Data from Open Label
Study Part B- Dosed Twice Daily with QRX003
End Point |
Baseline |
6 weeks (Treatment period midpoint) |
12 weeks (End of treatment period) |
4 weeks post discontinuation of treatment |
M-IASI* |
18 |
4 |
3 |
18 |
WINRS** |
7 |
4 |
2 |
8 |
IGA*** |
Moderate |
Mild |
Almost Clear |
Moderate |
*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.
Quoin CEO, Dr. Michael Myers, said, “This data
set provides the clearest clinical evidence to date that the active
ingredient in QRX003 is a competitive broad spectrum serine
protease inhibitor and that discontinuation of treatment with
QRX003 results in a complete reversal of all clinical benefits
derived from continued treatment with the product. The rapid
reversal of all observed clinical benefits to baseline disease
status after just 4 weeks of treatment discontinuation serves to
further underscore that chronic, whole-body treatment with QRX003
is potentially required to maintain the positive clinical outcomes
observed in our clinical study. These results increase our
commitment to complete the clinical development of QRX003 as
expeditiously as possible with a goal of making the product widely
available to the Netherton community once approved.
With four clinical studies in Netherton subjects
underway, three of which are being conducted under an open
Investigational New Drug (IND) application with the FDA, we believe
Quoin is assembling a broad and diverse clinical data package to
support a New Drug Application (NDA) filing for QRX003 as
potentially the first approved treatment for Netherton
Syndrome.”
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://quoinpharma.com/pipeline/#trials
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, the potential efficacy of QRX003 as a treatment for
Netherton Syndrome, the goal of making the product widely available
to the Netherton community once approved, we believe Quoin is
assembling a broad and diverse clinical data package to support a
New Drug Application (NDA) filing for QRX003 as potentially the
first approved treatment for Netherton 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)
過去 株価チャート
から 1 2025 まで 2 2025
Quoin Pharmaceuticals (NASDAQ:QNRX)
過去 株価チャート
から 2 2024 まで 2 2025