Quoin announces dosing of first patient in trial in Netherton Syndrome

Quoin Pharmaceuticals announces that the first patient has been dosed in its ongoing clinical trial evaluating the safety and efficacy of QRX003 as a treatment for Netherton Syndrome. Quoin’s first clinical trial is a randomized, double blinded, vehicle-controlled study which is being conducted under a U.S. Investigational New Drug, IND, Application and is assessing two different doses of QRX003 topical lotion versus a vehicle lotion in Netherton patients. The test materials are applied once daily over a twelve-week period, to pre-designated areas of the patient’s body. Based on discussions with the U.S. Food and Drug Administration, FDA, a number of different clinical endpoints will be assessed in the study. In October 2022, Quoin announced it plans to initiate a second study assessing its QRX003 topical lotion in Netherton patients who are currently receiving off-label treatment including systemic therapy for symptomatic relief. This second study, which has now been cleared by the FDA to initiate clinical testing, is an open-label, non-placebo controlled trial that will evaluate 10 Netherton patients over a twelve week period. The study, which will run concurrently with Quoin’s ongoing clinical trial, will be conducted at the same sites and by the same clinical investigators as the first study, thereby optimizing the potential for a rapid recruitment of patients. Quoin CEO, Dr. Michael Myers, said, "With over seventy potential candidates already having gone through our initial screening process, we have been delighted with the level of interest in our clinical programs that has been shown by the Netherton community. The dosing of our first patient and the clearance of our second study are big steps forward for Quoin and, hopefully, for the community in general. With all six clinical sites on track to be fully opened this month, we are hopeful that the rate of recruitment into both studies will accelerate rapidly going forward.