Quoin Pharmaceuticals provides regulatory update on QRX009 topical rapamycin

Quoin Pharmaceuticals (QNRX) 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. In addition, Quoin is planning to initiate investigator-led clinical studies in both Gorlin Syndrome and Tuberous Sclerosis Complex later this year. Finally, Quoin is on track to submit an investigational new drug application to the FDA for QRX009 for an additional indication in Q3 of this year. Michael Myers, CEO 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.”