Amryt's study of large herpes skin looseness was approved

Independent Data Monitoring Board (IDCM) recommended that Amryt's critical Phase III EASE trial on AP101 - a potential treatment for the currently incurable large herpes skin looseness (EB) - should continue.IDMC recommended that 48 additional patients be added to the study, for a total of 230 assessable patients, to achieve 80% statistical effectiveness.The news is an important milestone for Amryt, which will begin recruiting the additional patients needed and is now expected to read the best data from the EASE study in the second half of 2019.The EASE trial is the largest global study ever to study EB treatments, and continuation means that fortunately, the results show that treatments are effective and ultimately effective.EB is a devastating, rare inherited skin disease that causes the skin to blister and tear due to the slightest friction or trauma, and in some cases causes blisters and decay in the inner cortical layer of the internal organs.Around 500,000 people around the world live under EB, and there are 5,000 in the UK, of whom about 2,000 are managed in specialist centres, and there is no cure for the disease.The U.S. Food and Drug Administration approved AP101's New Research Drug (IND) license in September 2018, and U.S. pilots and other international sites are expected to contribute to the additional patient recruitment required.Joe Wiley, chief executive of Amryt Pharma, said: "The IDMC recommendation is good news for Amryt because it allows us to continue with the trials, but only modestly increases the scale of the research. This allows us to further treat potential EB patients. We would like to express our sincere gratitude to the patients, families and clinical researchers involved in the EASE trial. " (Compiled by this web)