Quoin Pharmaceuticals Ltd. 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). 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 an established network of U.S. and EU clinical trial sites, the company will be in a position to initiate a 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. This meeting represents an important milestone for Quoin and the Netherton Syndrome community at large. 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.