Quoin Pharmaceuticals Ltd. (QNRX) disclosed on Monday that the U.S. Food and Drug Administration (FDA) has approved the inclusion of teenagers aged 14 years and above in its two current clinical trials for QRX003. This drug is under development as a potential solution for Netherton Syndrome (NS).
The two trials are operating under Quoin's open Investigational New Drug Application (IND) for QRX003 and the approval covers adolescent patients partaking in both the firm's unblinded and placebo-controlled studies.
This landmark progression marks the first-ever incorporation of underage subjects in Netherton Syndrome clinical trials conducted under an open Investigational New Drug Application.