Quoin reports positive interim Phase 2/3 QRX003 data in Netherton Syndrome, adds PSS designations
Interim results from six patients met the primary and key secondary endpoints, while the FDA and EMA granted regulatory designations for QRX003 in Peeling Skin Syndrome.
Quoin Pharmaceuticals reported its third-quarter 2026 results on 5 November, alongside interim data from the Phase 2/3 study of QRX003 in Netherton Syndrome. According to the company, both the primary endpoint and a key secondary endpoint reached pre-specified statistical significance in the first six patients.
Quoin said no treatment-related serious adverse events were recorded in the interim analysis. The dataset is small and interim, and the company expects topline Netherton data in the second quarter of 2027.
On the regulatory side, the US Food and Drug Administration cleared an Investigational New Drug application for QRX003 in Peeling Skin Syndrome (PSS). The agency also granted Rare Pediatric Disease and Fast Track designations for that indication. The European Medicines Agency granted Orphan Drug Designation.
Quoin also disclosed a private placement of up to $50 million. The summary provided does not give further terms of the financing or details of how the proceeds will be used.
What it means for your team
- Regulatory teams tracking rare dermatology programmes should note the FDA IND clearance and the Rare Pediatric Disease and Fast Track designations in PSS, alongside EMA Orphan Drug Designation.
- Pharmacovigilance teams will want to see the full safety dataset, as the no-treatment-related-serious-adverse-events finding rests on only six patients at interim.
- Market-access and planning teams should treat the results as preliminary and watch for topline Netherton data expected in Q2 2027.
Company's press release (SEC filing): Quoin Pharmaceuticals Ltd. ↗
Article written by VigiEye from the official source (Quoin Pharmaceuticals Ltd.). Claims are the company's own. AI-assisted; check the source before acting.