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Archive Life Sciences Archive York Pharma to start new trial phase | York Pharma to start new trial phase |
| Friday, 02 November 2007 | |
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Following positive results from as recent study, dermatology specialist York Pharma has announced plans for a Phase IIb trial of its eczema treatment, Sabarep.
The Hitchin-based company said that following earlier positive results generated in a human study, conducted to validate the effects on the skin barrier and to confirm the final dosage composition of the product, plans are now progressing towards a Phase IIb clinical programme. It said that it had requested a pre-IND (Investigational New Drug application) conference with the US FDA to confirm that its planned programme meets the requirements for building a scientific and clinical dossier, which could lead the way to commercialising Sabarep in the US. “This development could simplify significantly the international approval of Sabarep and is the third product in York’s development pipeline to enter international clinical studies,” said CEO, Terry Sadler. “Although up to 25 per cent of children suffer from atopic eczema there are limited treatment choices available and, as a result there is a clear medical need for a non-steroidal treatment which can be used safely and effectively in children.’ |
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