Amryt Pharma flags slight delay to EASE trial data

(Sharecast News) - Orphan drug company Amryt Pharma updated the market on the global AP101 EASE Phase III clinical trial being conducted in patients with Epidermolysis Bullosa (EB) on Wednesday, reporting that the independent data monitoring committee was scheduled to meet on 21 December to review the EASE unblinded interim efficacy analysis results.The AIM-traded firm said it expected to receive the unblinded EASE interim efficacy data readout from the committee in early January, and would update the market at that time.At the time of its initial public offering, Amryt granted investors warrants to subscribe for an aggregate of 20,836,695 new ordinary shares at an exercise price of 24p, with an exercise date of 31 December 2018, to enable investors to benefit from the results of the EASE study.In order to reflect the revised timeline for the interim readout, Amryt said it was extending the exercise date of warrants issued to 11 January 2019.All other terms and conditions of the warrants, including the exercise price, remained unchanged.Amryt confirmed it had now opened its first US trial site for EASE.Five trials sites were initially planned in the United States, and the first site was described by the board as a "significant milestone" in accelerating patient recruitment into the EASE study.The first site in the US added to Amryt's existing trial sites in Europe, Australasia, Latin America and the Middle East.It said the US Food and Drug Administration (FDA) granted Investigational New Drug clearance for AP101 in September.Looking towards the results, Amryt's board said the interim readout would result in one of three possible outcomes, with the first possibility being the continuation of the study with no change to sample size, which would reflect conditional statistical power of at least 80% or better.The second possibility was to increase the number of patients in the study to maintain an 80% conditional statistical power, with the third being the discontinuation of the study due to futility.Amryt said the EASE Phase III clinical trial was the "largest ever" global Phase III study conducted in patients with EB.It described EB as a rare genetic skin disorder that could cause skin to blister and tear from the slightest friction or trauma and could, in some cases, cause blistering and erosion of the epithelial lining of internal organs.EB is "chronic, potentially disfiguring and life limiting", the board said, with approximately 500,000 people living with EB worldwide.There were currently no approved treatments, making the estimated market potential for AP101 worth more than €1bn."Initiation of the first trial site in the US allows us to further accelerate patient enrolment for EASE and crucially, means that eligible American sufferers of this rare condition will be able to take part in this potentially life changing trial," said Amryt Pharma chief executive officer Joe Wiley."We look forward to updating the market with the recommendation of the independent data monitoring committee following our unblinded interim efficacy analysis which potentially represents a significant milestone for the company."