Quoin Pharmaceuticals Doses First Patient in Open Label Netherton Syndrome Clinical Trial
ASHBURN, Va., March 21, 2023 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces the dosing of the first patient in its open label clinical trial in Netherton Syndrome patients.
The trial is a single arm, open label study, investigating the safety and efficacy of Quoin’s lead candidate, QRX003, in Netherton Syndrome patients who are currently receiving off-label systemic therapy, primarily biologic therapy, and will continue to do so throughout the duration of the study. QRX003 will be applied once daily over a twelve-week period to pre-designated areas of the patient’s body. A number of different clinical endpoints are being assessed in the study, including an Investigator Global Assessment (IGA), a Patient Global Assessment (PaGA), as well as pruritus, among others.
This study, which is Quoin’s second study in Netherton patients, is running concurrently with the company’s double blinded vehicle controlled study and is also being conducted under the company’s open Investigational New Drug (IND).
Quoin anticipates reporting topline data from this open-label study in the second half of 2023.
Quoin Pharmaceuticals CEO, Dr. Michael Myers, said, “We are pleased to announce the dosing of the first patient in this study. With our two clinical studies in Netherton patients actively recruiting and dosing patients, we are very encouraged by the level of interest and enthusiasm both of them are generating in the community as a whole.”
“If approved, QRX003 has the potential to become the standard of care for Netherton patients and our goal is to make the product as widely available as possible via a combination of our own planned commercial infrastructure in the US and Europe as well as through our global distribution partnership network that now covers 60 countries.”
In December 2022, the first patient was dosed in the company’s other clinical trial, a randomized, double blinded, vehicle-controlled study assessing two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton Syndrome patients.
We believe Quoin is the only pharmaceutical company actively conducting two clinical studies in Netherton patients under an open IND. The two studies are running concurrently and utilizing the same investigators and clinical sites, resulting in high levels of operational synergies and cost savings.
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 Syndrome
Netherton 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 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 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: