Quoin Pharmaceuticals Ltd., a late clinical-stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that it has been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for its lead product QRX003 in Netherton Syndrome.
Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved, QRX003 will be granted 10 years of market exclusivity in Europe for the treatment of Netherton Syndrome.
Quoin CEO, Dr. Michael Myers, said, “We continue to make important clinical and regulatory progress for QRX003 as a potential treatment for Netherton Syndrome, and this milestone marks yet another significant step forward for Quoin. As we continue to generate positive clinical results from our ongoing studies we are very encouraged both by the efficacy signals we are seeing and the clean safety profile of the product to date. In particular, the extent of skin healing observed coupled with the almost complete elimination of severe chronic pruritus in our investigator pediatric study underscores QRX003’s mechanism of action as a broad spectrum kallikrein inhibitor that has the potential to be a safe and effective treatment for this disease.”
QRX003 is currently being evaluated in multiple late-stage clinical trials and is designed to be a topical, non-systemic treatment for Netherton Syndrome, a devastating, life-altering disease for which there are currently no approved therapies.
