Quoin Pharmaceuticals Provides Clinical and Regulatory Update for QRX009 Topical Rapamycin Development Programs
Company Planning Multi-Pronged Approach for QRX009 Including Several Investigator Led Clinical Studies in Key Indications.
Company to Initiate Investigator Led Clinical Study in Pachyonychia Congenita
Study Will be Led By Professor Edel O'Toole, Queen Mary University of London, Globally Recognized Leader in Pachyonychia Congenita
Quoin Also Planning to Initiate Investigator Led Studies in Gorlin Syndrome and Tuberous Sclerosis Complex
In addition to the Investigator Led Studies Company is Targeting to File Investigational New Drug Application to US Food and Drug Administration for QRX009 for an additional indication in Q3 2026
Quoin has Established Relationships With Key Advocacy Foundations including The PC Project and The Gorlin Syndrome Alliance as well as with Leading KOLs and Clinicians
ASHBURN, Va., April 28, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) (the "Company" or "Quoin"), a late clinical stage specialty pharmaceutical company focused on rare and orphan diseases, today provided a clinical and regulatory update for its QRX009 topical rapamycin development programs. The Company is planning to initiate several investigator-led clinical studies for its QRX009 topical rapamycin lotion in a number of key target indications. The first study will be in, Pachyonychia Congenita (PC), a rare skin disease with no approved treatments or cure. This study will be led by Professor Edel O'Toole of Queen Mary University of London, a globally recognized clinician and thought-leader in PC who has previous experience in clinical trials for PC. Quoin believes that Professor O'Toole's expertise coupled with the Company's proprietary delivery technology could lead to improved clinical outcomes for PC patients over past studies. The Company is targeting initiating this study in Q3 of this year. In addition, Quoin is planning to initiate investigator-led clinical studies in both Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC) later this year. Finally, Quoin is on track to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for QRX009 for an additional indication in Q3 of this year.
Dr. Michael Myers, Chief Executive Officer of Quoin commented, "We are very pleased to provide this important update for our QRX009 topical rapamycin programs. Since we announced that we had achieved our target loading concentrations of 4% and 5% for our proprietary lotion and dermal patch delivery systems, we have been working diligently to advance our products into the clinic. We are delighted that Professor O'Toole has agreed to lead an investigator study in PC, a disease in which she has renowned expertise and deep clinical experience. In addition, we are pleased to have the opportunity to initiate investigator-led clinical studies in GS and TSC. On the regulatory front, we are on track to submit our first IND to the FDA for QRX009 in Q3 of this year for a separate indication and the potential exists for QRX009 to be in active testing in four separate clinical indications before the end of 2026. We view these opportunities as highly complementary to our ongoing late-stage program in Netherton Syndrome (NS) as well as our program in Peeling Skin Syndrome, for which we are also targeting an IND application in Q2, 2026. This is a very exciting time for Quoin as we continue our mission of targeting rare skin diseases for which there are no or limited approved treatments. 2026 is shaping up to be a transformational year for our Company not only as we advance to pivotal trials for QRX003 for the treatment of NS, but also as we move forward across these multiple fronts."
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, PC, GS, TSC, microcystic lymphatic malformations, venous malformations, angiofibromas 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 plans to initiate several investigator-led clinical studies for its QRX009 topical rapamycin lotion in a number of key target indications; the Company initiating investigator-led study in Pachyonychia Congenita; Professor O'Toole's expertise coupled with the Company's proprietary delivery technology leading to improved clinical outcomes for PC patients over past studies; initiating the study for QRX009 in Q3 of this year; plans to initiate investigator-led clinical studies in GS and TSC later this year; being on track to submit an IND to the FDA for QRX009 in Q3 of this year; working diligently to advance the Company's products into the clinic; the potential for QRX009 to be in active testing in four separate clinical indications before the end of 2026; targeting an IND application for Peeling Skin Syndrome in Q2 2026; targeting rare skin diseases for which there are no or limited approved treatments; 2026 shaping up to be a transformational year for the Company as it advances to pivotal trials for QRX003 for the treatment of NS and moves forward across multiple fronts; 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, PC, GS, TSC, microcystic lymphatic malformations, venous malformations, angiofibromas 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.
Dr. Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
