ASHBURN, Va. — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today provided a clinical and regulatory update from its recent constructive Type C meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome (NS).
“We are very pleased to provide this update from our recent Type C meeting with FDA. Importantly, FDA acknowledged that a single Phase 3 study may be sufficient to support U.S. marketing approval of QRX003 for Netherton Syndrome, rather than the two Phase 3 studies the Company had originally contemplated. With our established network of U.S. and EU clinical trial sites, we are confident that we will be in a position to initiate our pivotal Phase 3 program and fully complete recruitment this year. FDA also expressed openness to an alternative, innovative clinical trial design, such as a randomized withdrawal or randomized delayed start study, which may be more appropriate Phase 3 design in the setting of Netherton Syndrome than a traditional upfront randomized, controlled study. Overall, this meeting represents an important milestone for Quoin and the Netherton Syndrome community at large. We are now in a position to move forward with clarity, and we remain on track to advance development of QRX003 with the goal of potentially delivering the first approved medication for the treatment of Netherton Syndrome. Finally, I would like to sincerely thank each of the KOLs who participated in the meeting: Professor Alan Irvine, Dr. Amy Paller, Dr. Keith Choate, Professor Jemima Mellerio, Professor Anna Martinez, Professor James Halpern and Professor Suzanne Pasmans. We are truly grateful for your continued support and expert input.” said Dr. Michael Myers, CEO of Quoin Pharmaceuticals.
Key highlights from the meeting include:
- FDA indicated that a single Phase 3 study may be sufficient to support marketing approval for QRX003 for Netherton Syndrome, which is an alternative to the traditional expectation for two Phase 3 studies in NS patients originally proposed by the Company.
- FDA expressed openness to an alternative innovative clinical trial design such as a randomized withdrawal or a randomized delayed start for a pivotal Phase 3 study. Such trial design would likely not include a traditional upfront vehicle or placebo control.
Based on the feedback from the meeting, Quoin is implementing FDA recommendations consistent with the meeting outcomes, ensuring its readiness to advance toward registrational Phase 3 development. Quoin will submit clinical data from the ongoing Phase 2 and pediatric investigator studies and plans to request a meeting to discuss this data prior to initiating the Phase 3 pivotal program for QRX003 to gain alignment with FDA on the design of the program. Quoin remains on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to potentially file for FDA approval for QRX003 as the first treatment for Netherton Syndrome 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 comprises several products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
[email protected]
Investor Relations
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341