Full Press Release Details
Quoin Pharmaceuticals Announces FDA Clearance
of Clinical Optimization Plan for QRX003 for Netherton Syndrome
Positive initial data and clean safety
profile catalyze optimization plan
Size of both ongoing clinical trials
significantly increased
Lower dose eliminated from blinded
Dosing frequency changed to twice-daily
from once-daily for both trials
ASHBURN, Va., December 13, 2022 - 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.
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., CEO