ASHBURN, Va., June 30, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled "Combination Treatment for Netherton Syndrome."
The patent supports Quoin's intellectual property strategy for QRX003, its investigational treatment for Netherton Syndrome, a rare genetic skin disease for which there are currently no approved treatments.
Key Facts
- The USPTO has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled "Combination Treatment for Netherton Syndrome."
- The allowed claims cover a method of treating Netherton Syndrome using a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent.
- The claims include treatment of patients carrying SPINK5 mutations, the genetic basis of Netherton Syndrome.
- The patent will be granted following payment of the issue fee.
- QRX003 (QYLEKI), Quoin's investigational topical treatment for Netherton Syndrome, holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States and Orphan Drug Designation in the European Union and Japan.
- If approved, QRX003 has the potential to become the first approved treatment for Netherton Syndrome.
Patent Coverage
The allowed claims cover a method of treating Netherton Syndrome by administering a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent. The claims include treatment of patients who carry mutations in the SPINK5 gene, the genetic basis of the disease, and cover application to skin lesions on the arms and lower legs. The allowed claims add to Quoin's intellectual property position around its topical treatment approach for Netherton Syndrome and support the Company's long-term commercialization strategy for QRX003.
The Notice of Allowance indicates that the application has completed substantive examination and is expected to proceed to issuance following payment of the required fees. Once granted, the patent will add to the Company's intellectual property position in the United States covering its Netherton Syndrome program.
"The allowance of this patent is an important step in protecting the innovation behind our Netherton Syndrome program as we advance toward what could become the first approved treatment for this devastating disease," said Dr. Michael Myers, Co-Founder and Chief Executive Officer of Quoin Pharmaceuticals. "Securing intellectual property protection in the United States reinforces the long-term value of the program as we continue to build the clinical, regulatory, and commercial foundations for QRX003."
About Netherton Syndrome
Netherton Syndrome is a rare, serious genetic skin disease caused by mutations in the SPINK5 gene. The condition is characterized by impaired skin barrier function, persistent inflammation, and increased serine protease activity in the skin. There are currently no approved therapies in the United States indicated specifically for Netherton Syndrome.
About QRX003
QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan. The U.S. brand name QYLEKI has been accepted by the FDA. QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin's pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late 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 is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, microcystic lymphatic malformations, venous malformations, angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
Forward-Looking Statements
The Company cautions that statements in this press release that are not descriptions 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," "hope," "plan," "potential," "anticipate," "look forward," "believe," "may," and "will," among others. This press release contains forward-looking statements. 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: Quoin's strategy to directly commercialize QRX003 for the treatment of Netherton Syndrome, if approved; engaging directly with Japanese regulators, clinicians, and patient advocacy organizations as Quoin builds the commercial infrastructure to support a potential launch; self-commercializing QRX003 and the Company's other pipeline products in Japan, the United States and Western Europe; facilitating almost global availability of the product if approved; continuing to build the commercial infrastructure in advance of a potential approval; initiating Quoin's pivotal Phase 3 study in the second half of 2026, with a potential NDA filing in 2027; QRX003 having the potential to become the first approved treatment for Netherton Syndrome; working closely with leading Japanese clinicians to refine the clinical and regulatory pathway for approval of QRX003 for the treatment of Netherton Syndrome; and Quoin's 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, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and 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 including, but not limited to, the Company's ability to pursue its regulatory strategy; the Company's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company's ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 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. 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
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
