Quoin Pharmaceuticals (NASDAQ: QNRX) announced that the FDA has provided clearance to initiate a second Netherton Syndrome (NS) clinical pivotal study—CL-QRX003-002, for Quoin’s lead product QRX003.
According to Quoin, clinical data from ongoing studies has demonstrated clear evidence of rapid, prolonged, and almost complete skin healing following a twice-daily application of QRX003 to the treatment areas, along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus, with zero nightly sleep disturbances.
In a statement, Dr. Michael Myers, CEO of Quoin commented, “I am very pleased to announce yet another important and significant milestone for Quoin. With FDA clearance to conduct this study, Quoin is the only company conducting two late-stage whole-body pivotal clinical studies in NS patients. We believe that the combined data generated from study CL-QRX003-003, where QRX003 is being administered as monotherapy and this study, CL-QRX003-002, where QRX003 is being tested in conjunction with off-label systemic therapy, has the potential to generate a highly comprehensive safety and efficacy data package that could support the regulatory approval of a treatment for this dreadful disease.”
