4th Jan 2019 13:32
LONDON (Alliance News) - Amryt Pharma PLC on Friday said an independent data monitoring committee has recommended adding more patients to its phase three Ease trial of epidermolysis bullosa drug AP101.
Shares in Amryt were up 7.7% at 18.37 pence on Friday afternoon in London.
The committee recommended continuing the study and adding another 48 epidermolysis bullosa patients, bringing the total patients for evaluation to 230.
Epidermolysis bullosa is the name given to a number of rare disorders that cause a patient to have fragile skin that is susceptible to painful blisters, with approximately 500,000 people living with the condition worldwide.
The committee's recommendation was based on data from the first half of the study, and the goal of these changes is for the Ease trial to achieve 80% statistical power.
Amryt said it will begin recruitment of the 48 patients and now expects a readout of the top line data from the study in the second half of 2019.
Amryt Chief Executive Joe Wiley said the committee's recommendation is "good news" as it allows the trial to continue with only a "modest increase" in patient numbers.
"Today's news is a significant milestone for Amryt and our shareholders in building towards our vision of becoming a global leader in rare and orphan diseases," Wiley said.
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