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Update on AP 101 trial as a potential treatment for epidermolysis bullosa.- Amryt

Written by | 23 Apr 2020 | Pharmacy

Amryt announced the results of an unblinded interim efficacy analysis on its pivotal Phase III EASE trial for AP 101 as a potential treatment for Epidermolysis Bullosa (“EB”).The analysis was conducted by an Independent Data Monitoring Committee (“IDMC”)

The IDMC recommended that the trial should continue with an increase of 48 patients in the study to a total of 230 evaluable patients, in order to achieve 80% statistical power. The analysis was conducted using unblinded efficacy data received by the IDMC for the primary endpoint from the first half of the study. Amryt will- begin the recruitment process for the additional patients required and now expects a readout of the top line data from the EASE study in H2 2019.

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