Amryt Pharma PLC Phase 3 Clinical Trial for AP101 commenced (6782A)
28 March 2017 - 5:01PM
UK Regulatory
TIDMAMYT
RNS Number : 6782A
Amryt Pharma PLC
28 March 2017
28 March 2017
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Phase 3 Clinical Trial for AP101 in EB
First Site Initiated
Amryt, the pharmaceutical company focused on best-in-class
treatments for rare and orphan diseases, is pleased to announce the
commencement of "EASE", its Phase 3 clinical trial of AP101,
Amryt's lead drug candidate, which offers a potential treatment for
Epidermolysis Bullosa ("EB"). EB is a rare, genetic skin disorder,
which causes exceptionally fragile skin.
The Company has initiated the first site for EASE in Sydney,
Australia, and will randomise the first patient within the next few
days. As previously reported, Amryt expects to conduct EASE in
approximately 15 countries at over 30 sites to enrol a total of 164
evaluable patients. Patients will be randomised in a double-blind
fashion to AP101 or placebo, and the proportion of patients with
completely healed target wounds within 45 days will be evaluated as
the primary efficacy endpoint.
EB is a chronic and debilitating condition that causes the skin
to blister and tear at the slightest touch and for which there is
currently no known cure. 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.
Mark Sumeray, Chief Medical Officer of Amryt, commented:
"We are delighted to have initiated the first site participating
in our Phase 3 clinical for AP101, which offers a potential
treatment for the rare, genetic skin condition, Epidermolysis
Bullosa or EB. Our study, EASE, is of substantial size for such a
rare disease and offers the opportunity to evaluate a new topical
treatment with the potential to accelerate wound healing in this
devastating disorder."
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 recently acquired an exclusive licence to sell
LOJUXTA (lomitapide), across the EU and other territories including
the Middle East, North Africa, Turkey and Israel. LOJUXTA is used
to treat a rare life-threatening disease called Homozygous Familial
Hypercholesterolemia.
Amryt's product, AP101 (Episalvan), received marketing approval
for the treatment of partial-thickness wounds from the European
Commission in January 2016. Amryt intends to develop AP101
(Episalvan) as a new treatment for Epidermolysis Bullosa ("EB"), a
rare and distressing genetic skin disorder affecting young children
for which there is currently no treatment. The Company recently
received regulatory clarity from the FDA and the EMA regarding its
Phase 3 study of AP101 (Episalvan) in EB, which has been granted US
and EU orphan drug designation, and is on track to commence this
study towards the end of March 2017. 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. AP102 was recently granted orphan designation in
the US in acromegaly by the FDA.
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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