Quoin Pharmaceuticals Announces International Expansion of Ongoing Clinical Trials for Netherton Syndrome
Quoin Pharmaceuticals (NASDAQ: QNRX) announces the international expansion of its clinical trials for Netherton Syndrome. The first international site will open at a research hospital in Saudi Arabia, which is currently treating eligible Netherton patients. An experienced local Clinical Research Organization will manage the study. The site will operate under Quoin's IND application with the US FDA. Additional international sites are also being planned. CEO Dr. Michael Myers highlighted that this expansion aims to accelerate patient recruitment and diversify the patient population. Quoin is conducting two ongoing trials evaluating QRX003, a topical lotion, for Netherton Syndrome.
- Quoin Pharmaceuticals is expanding its clinical trials for Netherton Syndrome internationally.
- The first international site in Saudi Arabia will recruit patients already being treated for Netherton Syndrome.
- An experienced local Clinical Research Organization has been engaged to manage the study.
- Plans for additional international sites are advanced.
- This expansion aims to speed up recruitment and diversify the patient population.
- None.
The expansion of clinical trials to international sites is a significant development for Quoin Pharmaceuticals. Netherton Syndrome is a rare genetic disorder and expanding the trials to Saudi Arabia where there are existing patients can potentially accelerate patient recruitment. This move not only diversifies the participant pool but also enhances the statistical robustness of the trial results by including a wider demographic. The involvement of an experienced local Clinical Research Organization further ensures that the trials will meet all regulatory requirements, thus maintaining integrity and reliability of the data collected.
From an investor's perspective, this expansion demonstrates the company's commitment to advancing its clinical trials, a critical step towards achieving regulatory approval and ultimately commercialization. However, it's important to consider the operational challenges and additional costs associated with managing international sites, which could impact the company's financials in the short term. In the long term, successfully navigating these challenges could position Quoin Pharmaceuticals as a leader in treating this underserved patient population.
Quoin Pharmaceuticals' decision to expand its clinical trials internationally can be seen as a strategic move to enhance the company's valuation and investor confidence. By increasing the scale and scope of its trials, Quoin is demonstrating its commitment to bringing QRX003 to market. This can be particularly appealing to investors looking for companies with a clear path to commercialization. The fact that the trials will be operated under the company's US FDA IND application adds an additional layer of oversight and credibility.
However, international expansions come with increased operational costs, regulatory complexities and logistical hurdles. Investors should closely monitor the company's cash burn rate and funding needs as these trials progress. If successful, this expansion could lead to regulatory approvals in multiple jurisdictions, broadening the market for QRX003 and potentially leading to significant revenue growth.
Clinical site to be Opened in Saudi Arabia
Site Currently Treating Netherton Patients Who Are Eligible for Recruitment into Quoin Studies
Experienced Local Clinical Research Organization Has Been Engaged
Plans for the Opening of Additional International Sites at an Advanced Stage
ASHBURN, Va., June 27, 2024 (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 that it will expand its ongoing Netherton Syndrome clinical studies to include international sites. The first international site will be opened at a research hospital in Saudi Arabia. This hospital is currently treating a number of Netherton patients who will now become eligible for recruitment into Quoin’s studies. An experienced Clinical Research Organization has been engaged to manage the study locally. The Saudi site will operate under the auspices of Quoin’s open Investigational New Drug (IND) application with the US Food and Drug Administration. Plans to open additional international clinical sites are at an advanced stage.
Quoin CEO, Dr. Michael Myers, said, “We are very pleased to announce this exciting development for our ongoing clinical studies. We hope that the opening of this first international site, which is currently treating Netherton patients, will speed up overall recruitment into our studies whilst expanding the diversity of the patient population being tested. We are working hard to open additional international sites to augment the five sites that are currently open in the US. Quoin is committed to completing recruitment into our clinical studies as expeditiously as possible with a view to potentially delivering the first approved treatment to this underserved patient population.”
Quoin is conducting two ongoing clinical trials evaluating QRX003, a topical lotion, for the treatment of Netherton Syndrome. For more information about the trials, 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 five 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.
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. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to the conference’s aim of connecting individuals seeking information about ichthyosis and other skin disorders, the Company delivering a safe and effective treatment for Netherton Syndrome as expeditiously as possible, and the Company’s four products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis. 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 ability to deliver a safe and effective treatment for Netherton Syndrome, the preclinical and clinical studies of the Company’s product candidates may not be successful and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that the Company filed with the SEC and the Company’s subsequent filings with the SEC on Forms 10-Q and 8-K. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. 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:
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
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