Quoin Pharmaceuticals Announces Additional Positive Clinical Data from Open-Label, Single-Arm Clinical Trial in Netherton Syndrome
October 24 2023 - 8:28AM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a specialty pharmaceutical company focused on rare and
orphan diseases, announces additional positive clinical data from
its ongoing open-label study evaluating the safety and efficacy of
QRX003 as a potential treatment for Netherton Syndrome (NS).
This study, which is being conducted under
Quoin’s open Investigational New Drug (IND) application, is an
open-label, single-arm trial that is evaluating 10 NS patients
dosed with QRX003 over a twelve week period. All subjects in the
study are continuing to receive off-label systemic therapy for the
duration of the trial.
Of the available data from six evaluable
subjects, five demonstrated a well-defined positive improvement in
pruritus, or itch, with those five subjects reporting absent or
negligible pruritus on completion of dosing with QRX003 based on
the endpoint scoring system. The sixth subject’s pruritus was
effectively unchanged on completion of dosing with QRX003. In the
Investigator assessed skin scoring system, all six patients
experienced an improvement in skin appearance, with three of the
six subjects demonstrating improvement throughout the study, while
for the other three subjects, signs of improvement were exhibited
at various points throughout the dosing period. Importantly, all of
the 6 subjects indicated a positive impression of QRX003 across a
number of key metrics.
The initial safety data across all patients is
highly supportive of further product development with no reported
treatment related adverse events impacting the study.
Quoin CEO, Dr. Michael Myers, said, “While
acknowledging that this is still early stage data, we are very
pleased to announce today additional positive results from our
ongoing open-label study in Netherton Syndrome. In August of this
year, we announced positive data from the first subject, who
completed the 12-week dosing period in the study, and I’m now
delighted to provide a further positive update for an additional
five subjects.
“The results for pruritus are particularly
encouraging, as this often causes significant distress for
Netherton patients. In addition, there are well defined efficacy
signals across the other evaluated endpoints including skin
appearance and the subjects’ own impression of how QRX003 performed
throughout the study, indicating that QRX003 may have the potential
to become an effective treatment for Netherton Syndrome.
Furthermore, the absence of any safety concerns from the study to
date is a positive indicator for the ongoing clinical development
of the product.
“With these results in hand, we are moving into
an optimization phase for this study as well as our ongoing double
blinded clinical trial and we look forward to providing updated
information on this, at the appropriate time.
“Netherton Syndrome is a devastating and
sometimes fatal rare disease. Quoin is fully committed to
delivering what may have the potential to become the first approved
treatment option to this underserved patient population.”
The active ingredient in QRX003 is a
broad-spectrum serine protease inhibitor, whose mechanism of action
is intended to down-regulate the hyperactivity of skin kallikreins,
leading to a more normalized rate of skin shedding. If proven to be
safe and effective, long term daily application of QRX003 could
lead to the development of a more normally functioning skin barrier
and a significant improvement in the quality of life of Netherton
patients.
For more information about Quoin’s clinical
trials in Netherton Syndrome, 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.
About Netherton
SyndromeNetherton Syndrome is a rare and sometimes fatal
skin disease for which there is no approved treatment, and no cure.
It is caused by a mutation of the SPINK5 gene which leads to
uncontrolled skin shedding, resulting in a highly porous and
ineffective skin barrier. Symptoms are present at birth and include
red, scaly skin. Other symptoms include outbreaks of red, circular
scaly rashes, thin, fragile hair (bamboo hair), and immune
reactions such as hay fever, asthma, severe pruritus (itchy skin),
and eczema. Dehydration and infection are common and can be serious
or fatal. Babies tend to grow slowly and have poor weight gain.
Netherton Syndrome is inherited in an autosomal recessive
pattern.
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. 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. More
detailed information about the risks and uncertainties affecting
the Company is contained under the heading "Risk Factors" included
in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2022 that the Company filed with the SEC. One should
not place undue reliance on these forward-looking statements, which
speak only as of the date on which they were made. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. 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., CEO
mmyers@quoinpharma.com Investor RelationsPCG AdvisoryStephanie
Princesprince@pcgadvisory.com(646) 863-6341
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