19 Dec 2018 07:00
19 December 2018
AIM: AMYTESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Update on ongoing AP101 Trial
Amryt, a revenue generating orphan drug company focused on acquiring, developing & commercialising products that help improve the lives of patients where there is a high unmet medical need, today provides the following update regarding the global AP101 EASE Phase III clinical trial being conducted in patients with Epidermolysis Bullosa ("EB").
· Amryt has received notification that the Independent Data Monitoring Committee ("IDMC") is scheduled to meet on 21 December to review the EASE unblinded interim efficacy analysis results. The Company expects to receive the unblinded EASE interim efficacy data readout ("Interim Readout") from the IDMC in early January and will update the market at that time.
· At the time of the Company's IPO investors were granted warrants to subscribe for an aggregate of 20,836,695 New Ordinary Shares at an exercise price of 24p sterling 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, the Company is extending the exercise date of warrants issued to 11 January 2019. All other terms and conditions of the warrants, including the exercise price, remain unchanged.
· Amryt has opened its first US trial site for EASE. Five trials sites are initially planned in the US and this first site is a significant milestone in accelerating patient recruitment into the EASE study. This first site in the US adds to Amryt's existing trial sites in Europe, Australasia, Latin America and the Middle East. The US Food and Drug Administration ("FDA") granted Investigational New Drug ("IND") clearance for AP101 in September 2018.
The Interim Readout, referred to in bullet point one above, will result in one of three possible outcomes:
· Continue the study with no change to sample size, which would reflect conditional statistical power of at least 80% or better
· Increase the number of patients in the study to maintain an 80% conditional statistical power
· 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. EB is a rare genetic skin disorder that can cause skin to blister and tear from the slightest friction or trauma and can, in some cases, cause blistering and erosion of the epithelial lining of internal organs. EB is chronic, potentially disfiguring and life limiting. There are approximately 500,000 people living with EB worldwide and there are currently no approved treatments.1 It is estimated that the market potential for AP101 is more than €1 billion.
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. 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."
1https://www.debra.org.uk/what-is-eb/what-is-eb
Enquiries:
Amryt Pharma plc | +353 (1) 518 0200 |
Joe Wiley, CEO Rory Nealon, CFO/COO
|
|
Shore Capital | +44 (0) 20 7408 4090 |
NOMAD and Joint Broker |
|
Edward Mansfield, Mark Percy, Daniel Bush
|
|
Stifel | +44 (0) 20 7710 7600 |
Joint Broker |
|
Jonathan Senior, Ben Maddison
|
|
Davy | +353 (1) 679 6363 |
ESM Adviser and Joint Broker |
|
John Frain, Anthony Farrell
|
|
Consilium Strategic Communications | +44 (0) 20 3709 5700 |
Matthew Neal, David Daley, Nicholas Brown |
|
About Amryt
Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases.
Lojuxta is an approved treatment for adult patients with the rare cholesterol disorder - Homozygous Familial Hypercholesterolaemia ("HoFH"). This disorder impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature narrowing and blocking of blood vessels, heart attacks and strokes, even at a very young age if not properly diagnosed or receiving adequate treatment. Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without LDL apheresis in adult patients with HoFH.
Amryt is the marketing authorisation holder and has an exclusive licence to sell Lojuxta (lomitapide) across the European Economic Area, Middle East and North Africa, Switzerland, Turkey, Israel, Russia, the Commonwealth of Independent States and the non-EU Balkan states.
Amryt's lead drug candidate, AP101, is a potential treatment for Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no treatment. It is currently in Phase III clinical trials. The European and US market opportunity for EB is estimated to be in excess of €1 billion.
In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.
For more information on Amryt, please visit amrytpharma.com