Quoin Pharmaceuticals Announces FDA Clearance of Clinical Optimization Plan for QRX003 for Netherton Syndrome
December 13 2023 - 8:30AM
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or
“Quoin”), a specialty pharmaceutical company focused on rare and
orphan diseases, today announced that it has received U.S. Food and
Drug Administration (FDA) clearance to implement a number of
protocol amendments to 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.
“We are extremely pleased to announce clearance
of our clinical trial optimization plan for QRX003 in NS. Armed
with positive initial data and a clean safety profile to date, we
believe that these protocol amendments could ultimately result in
the generation of a highly compelling data set which could support
regulatory filings and approval for QRX003 as the first treatment
for this terrible disease. These latest developments underscore
Quoin’s continued commitment to delivering a safe and effective
treatment for this very underserved patient population,” said Dr.
Michael Myers, Chief Executive Officer of Quoin.
As a result of positive initial clinical data
across multiple endpoints and a strong safety profile to date,
Quoin has made a number of protocol amendments to both ongoing
trials. The company believes that implementation of these protocol
amendments may result in an even more robust data set and
potentially more rapid approval with a broader label.
The number of subjects in the blinded trial is
increased to 30 from 18. As a result of the positive safety profile
observed to date, the lower 2% dose has been eliminated from the
trial going forward. All subjects will now receive either 4% QRX003
or a placebo vehicle, both of which will be applied twice-daily
instead of the current once-daily treatment.
The number of subjects in the open-label trial
is increased to 20 from 10, and the dosing frequency will also be
twice-daily going forward. All subjects in this trial will continue
to receive off-label systemic therapy throughout the duration of
treatment.
All current clinical endpoints for both trials
will remain the same and Quoin plans to open additional clinical
sites to efficiently accommodate this increase in the number of
enrolled subjects. Interest from subjects and clinical
investigators continues to be very high and Quoin remains the only
company actively recruiting subjects into NS clinical trials that
are being conducted under an open IND.
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. 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 20-F filed with the SEC on
April 14, 2022, 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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