Amryt Pharma PLC First Patient Enrolled (0543D)
April 24 2017 - 2:00AM
UK Regulatory
TIDMAMYT
RNS Number : 0543D
Amryt Pharma PLC
24 April 2017
24 April 2017
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Phase 3 Clinical Trial for AP101 in EB
First Patient Enrolled
Amryt, the pharmaceutical company focused on best-in-class
treatments for rare and orphan diseases, is pleased to announce
that the first patient has now been enrolled into "EASE", the
Company's pivotal Phase 3 clinical trial, which is evaluating AP101
as a potential treatment for the rare, genetic skin disorder,
Epidermolysis Bullosa ("EB").
As previously reported, EASE intends to study 164 patients
across approximately 30 sites in 15 countries, with the first site
initiated in Sydney, Australia. Patients will be randomised in a
double-blind fashion to AP101 or placebo, with the treatment
applied as a topical gel when dressing changes would routinely
occur but no less frequently than every four days.
The proportion of patients with completely healed target wounds
within 45 days will be evaluated as the primary efficacy endpoint.
The trial is being conducted by INC Research as the contract
research organisation. An interim analysis will be conducted when
50% of the study patients have completed 45 days of treatment. The
results from this interim analysis of this trial are expected in
the first quarter of 2018.
EB is a chronic and debilitating disease which causes the skin
to tear and blister at the slightest touch. There are approximately
500,000 people living with EB worldwide and the global market for a
treatment in EB is estimated to be in excess of EUR 1.3 billion.
Currently, there is no approved therapy to treat EB.
Mark Sumeray, Chief Medical Officer of Amryt, commented:
"We are delighted to enrol the first patient in EASE, our
pivotal Phase 3 clinical trial. The trial will evaluate the
efficacy and safety of our lead drug candidate, AP101, as a
potential treatment for Epidermolysis Bullosa, a distressing and
rare skin disorder. We look forward to further patients joining the
study, which we expect to be one of the largest studies of its kind
in this rare disease."
Enquiries:
Amryt Pharma plc C/o KTZ Communications
Joe Wiley, CEO
Rory Nealon, CFO/COO
+44 (0) 20
Shore Capital 7408 4090
Nomad and Joint Broker
Bidhi Bhoma, Edward Mansfield
+353 (1) 679
Davy 6363
ESM Adviser and Joint
Broker
John Frain, Anthony Farrell
+44 (0) 20
Stifel 7710 7600
Joint Broker
Jonathan Senior, Ben
Maddison
+44 (0) 20
KTZ Communications 3178 6378
Katie Tzouliadis, Emma
Pearson
About Amryt Pharma plc - see www.amrytpharma.com
Amryt Pharma is a specialty pharmaceutical company focused on
developing and delivering innovative new treatments to help improve
the lives of patients with rare or orphan diseases. The Company is
building a diversified portfolio of commercially attractive,
best-in-class, proprietary new drugs to help address some of these
rare and debilitating illnesses for which there are currently no
available treatments.
The Company holds an exclusive licence to sell LOJUXTA
(lomitapide) for adults, across the EU and other territories
including the Middle East, North Africa, Turkey and Israel. LOJUXTA
is used to treat a rare life-threatening, genetic disorder called
Homozygous Familial Hypercholesterolemia, which impairs the body's
ability to remove LDL cholesterol ("bad" cholesterol) from the
blood. This typically results in extremely high blood LDL
cholesterol levels leading to aggressive and premature narrowing
and blocking of arterial blood vessels. If left untreated, heart
attack or sudden death may occur in childhood or early
adulthood.
Amryt's lead drug candidate, AP101 (Episalvan), is a potential
treatment for Epidermolysis Bullosa ("EB"), a rare and distressing
genetic skin disorder for which there is currently no treatment. It
is currently in Phase 3 clinical trials. The global market
opportunity for EB is estimated to be in excess of EUR 1.3
billion.
Amryt's earlier stage product, AP102, is focused on developing
novel, next generation somatostatin analogue ("SSA") peptide
medicines for patients with rare neuroendocrine diseases, where
there is a high unmet medical need, including acromegaly and
Cushing's disease.
The Company joined AIM and Dublin's ESM in April 2016 following
the reverse takeover of Fastnet Equity PLC.
This information is provided by RNS
The company news service from the London Stock Exchange
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