other material
confidence high
sentiment positive
materiality 0.65
Quoin receives FDA clearance to expand QRX003 trials; blinded trial to 30 subjects, dose changed to 4% twice daily
Quoin Pharmaceuticals, Ltd.
- FDA cleared protocol amendments for both ongoing QRX003 trials for Netherton Syndrome.
- Blinded trial increased from 18 to 30 subjects; lower 2% dose eliminated, all now receive 4% QRX003 or placebo twice daily.
- Open-label trial expanded from 10 to 20 subjects; dosing frequency changed to twice daily with continued off-label systemic therapy.
- Decision based on positive initial data and clean safety profile; all clinical endpoints unchanged.
- Quoin plans to open additional clinical sites to accommodate increased enrollment.