The AIM-listed company also said it has received notification that the Independent Data Monitoring Committee is scheduled to meet on 21 December to review the EASE data.
READ: Amryt Pharma receives €8.4mln from Irish government to develop treatment for rare skin condition
The firm added that it expects to receive the unblinded EASE interim efficacy data readout from the IDMC in early January and will update the market at that time. In a note to clients, analysts at 'house' broker Shore Capital pointed out that previously it was assumed that the readout would occur in late fourth quarter 2018.
It said the interim data readout will result in one of three possible outcomes – continuation of the study with no change to sample size, which would reflect conditional statistical power of at least 80% or better; an increase in the number of patients in the study to maintain an 80% conditional statistical power; or discontinue the study due to futility.
The EASE Phase III clinical trial is the largest ever global Phase III study conducted in patients with EB which is a rare genetic skin disorder that can cause the skin to blister and tear from the slightest friction or trauma.
There are approximately 500,000 people living with EB worldwide and there are currently no approved treatments and it is estimated that the market potential for AP101 is more than €1bn.
US site significant milestone
Amryt Pharma said five trials sites are initially planned in the US and the first site is a significant milestone in accelerating patient recruitment into the EASE study.
The US Food and Drug Administration granted Investigational New Drug clearance for AP101 in September 2018.
The US site adds to Amryt Pharma's existing trial sites in Europe, Australasia, Latin America and the Middle East.
Joe Wiley, CEO of Amryt Pharma, commented: "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.”
He added: “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."
Warrants exercise data revised
Amryt Pharma also pointed out that at the time of its IPO investors were granted warrants to subscribe for an aggregate of 20,836,695 new ordinary shares at an exercise price of 24p each with an exercise date of 31 December 2018 to enable investors to benefit from the results of the EASE study.
However, in order to reflect the revised timeline for the Interim Readout, the company said it is extending the exercise date of those warrants issued to 11 January 2019.
In mid-morning trading, Amryt Pharma shares were holding steady at 14.75p.
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