Amryt Pharma Gets Go-Ahead For Phase 3 Trial Of Skin Disorder Drug

LONDON (Alliance News) - Amryt Pharma PLC on Monday said it is on track to commence the phase 3 ...

Alliance News 6 March, 2017 | 11:05AM
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LONDON (Alliance News) - Amryt Pharma PLC on Monday said it is on track to commence the phase 3 trial of AP101 at the end of March after completing regulatory discussions with the US Food & Drug Administration and the European Medicines Agency.

AP101 is being trialled as a potential treatment for epidermolysis bullosa, which is a rare genetic skin disorder which leads to exceptionally fragile skin.

Approximately 30 clinical trial sites in 15 countries have been pre-qualified for the trial, where 164 patients will be treated for a 90-day period.

"We are delighted to have reached this critical milestone in the development of Amryt. Reaching agreement with the regulatory authorities for our phase 3 study in EB was a precursor to commencing our pivotal study, which we now expect will enrol its first patients in the coming weeks," Chief Executive Joe Wiley said in a statement.

"We believe that the adaptive approach to study sample size will help to ensure that we achieve a reliable assessment of the potential benefit of our new skin healing treatment in this orphan disease," Chief Medical Officer Mark Sumeray added.

Shares in Amryt were trading up 7.4% at 19.60 pence on Monday.

By Karolina Kaminska; karolinakaminska@alliancenews.com; @KarolinaAllNews

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Amryt Pharma PLC 16.38 GBX 0.00 -
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