Quoin Pharmaceuticals announces FDA clearance for plan for QRX003 trials

Quoin Pharmaceuticals announced that it has received U.S. Food and Drug Administration, FDA, clearance to implement a number of protocol amendments to its two ongoing clinical trials for QRX003, which is being developed as a potential treatment for Netherton Syndrome, NS. Both trials are being conducted under Quoin’s open Investigational New Drug Application, IND, for QRX003. “We are extremely pleased to announce clearance of our clinical trial optimization plan for QRX003 in NS. Armed with positive initial data and a clean safety profile to date, we believe that these protocol amendments could ultimately result in the generation of a highly compelling data set which could support regulatory filings and approval for QRX003 as the first treatment for this terrible disease. These latest developments underscore Quoin’s continued commitment to delivering a safe and effective treatment for this very underserved patient population,” said Dr. Michael Myers, Chief Executive Officer of Quoin. As a result of positive initial clinical data across multiple endpoints and a strong safety profile to date, Quoin has made a number of protocol amendments to both ongoing trials. The company believes that implementation of these protocol amendments may result in an even more robust data set and potentially more rapid approval with a broader label.