Quoin Pharmaceuticals Announces FDA Clearance to Recruit Teen Subjects into Both Ongoing Netherton Syndrome Clinical Studies
04 März 2024 - 2:00PM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a specialty pharmaceutical company focused on rare and
orphan diseases, today announced clearance from the U.S. Food and
Drug Administration (FDA) to recruit teen subjects aged 14 years
and older into its two ongoing clinical trials for QRX003, which is
being developed as a potential treatment for Netherton Syndrome
(NS). Both trials are being conducted under Quoin’s open
Investigational New Drug Application (IND) for QRX003.
Dr. Michael Myers, Chief Executive Officer of
Quoin, said, “We are very pleased to announce this exciting
development, not just for Quoin’s clinical program, but for the
Netherton community as a whole. We are frequently petitioned by
parents and caregivers that teen subjects be allowed to participate
in our clinical studies, given the severity of the disease and the
absolute dearth of viable treatment options. Today, it is our
privilege to announce that we have FDA clearance to do just
that.
“This FDA clearance represents the very first
time that non-adult Netherton subjects will be tested in clinical
studies conducted under an open-IND and, as such, represents a very
significant and important step forward for members of this
community. Significantly, teens who are currently receiving
off-label systemic therapy will be eligible to participate in our
open-label study, while those who are not receiving such therapy
may be recruited into the placebo controlled blinded study. This
important feature not only widens the pool of eligible subjects but
also eliminates the need for parents or caregivers to make
difficult decisions about treatments these patients and loved ones
are receiving. The inclusion of this patient population in our
studies will be, we believe, a critical component of the
development of a robust data set that could result in regulatory
approval with a broad label as QRX003 is being tested both as
monotherapy and in conjunction with off-label treatments.
“Quoin remains fully committed to the Netherton
community, their families and treating physicians, and we are proud
to be the only company actively dosing Netherton subjects in
clinical studies conducted under an open IND. We look forward to
continuing our mission to deliver what we hope will be the first
safe and effective treatment for this debilitating disease,”
concluded Dr. Myers
For more information about Quoin’s clinical
trials in Netherton Syndrome, please visit:
https://www.nethertonsyndromeclinicaltrials.com/
About Netherton Syndrome
Netherton 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 also 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 QRX003
QRX003 is a topical lotion, formulated with a
proprietary delivery technology, and 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 lead to a more normalized skin shedding
process and the formation of a stronger and more effective skin
barrier.
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 three 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, Epidermolysis Bullosa and
others. For more information, go to: www.quoinpharma.com.
Cautionary Note Regarding Forward Looking
Statements
The 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. These
forward-looking statements are based upon current estimates and
assumptions and include statements regarding the clearance to treat
teens expected to significantly expand the number of eligible
subjects, potentially expedite recruitment and lead to a more
robust data set; inclusion of the teen patient population in the
Company’s studies being a critical component of the development of
a robust data set that could result in regulatory approval with a
broad label and the hope that QRX003 will be the first safe and
effective treatment for this debilitating disease. 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 may not be able to
recruit teen subjects into its two ongoing clinical studies, the
clinical studies may not be successful and the Company may not be
able to obtain regulatory approval for QRX003. 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 filed with the SEC on March
15, 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. 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.,
CEOmmyers@quoinpharma.com
Investor RelationsPCG AdvisoryStephanie
Princesprince@pcgadvisory.com(646) 863-6341
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