Amryt Pharma PLC Pre-clinical study results (0467W)
February 06 2017 - 1:00AM
UK Regulatory
TIDMAMYT
RNS Number : 0467W
Amryt Pharma PLC
06 February 2017
AIM: AMYT
ESM: AYP
Amryt Pharma plc
("Amryt" or the "Company")
Positive pre-clinical study results for
drug compound with potential to treat acromegaly, AP102
Amryt, the pharmaceutical company focused on best-in-class
treatments for rare and orphan diseases, announces positive results
of a newly completed pre-clinical study that compared its drug
compound AP102 (a somatostatin analogue therapy with the potential
to treat acromegaly) with pasireotide, an approved product for
treating patients with resistant acromegaly. Amryt's AP102 did not
demonstrate the potential to cause diabetes, an observation which,
if replicated in clinical studies, could be clinically beneficial
in treating acromegaly. As previously reported, the Company is
preparing AP102 for clinical trials in 2017.
Amryt's study used a well-established diabetic rat model to
examine whether or not AP102 has an effect on glucose levels or on
food/water intake compared with controls. The study results showed
that AP102 had no effect on either in diabetic rats compared with
controls. This indicates no impairment in glucose control in these
diabetic animals when treated with AP102.
Mark Sumeray, Chief Medical Officer of Amryt Pharma,
commented:
"We are very pleased to report these study results that indicate
that our drug compound, AP102, does not impact glucose levels or
food or water intake, when administered to diabetic rats. This
suggests that it lacks the potential to cause or exacerbate
diabetes, which is an issue with some other approved therapies.
These positive data results are encouraging and further
reinforce our view that AP102 has the potential to improve outcomes
for patients suffering from acromegaly, a rare and very distressing
disorder which leads to excess growth of the body's tissues over
time.
As we previously reported in early November, the U.S. Food and
Drug Administration granted orphan drug designation to AP102 and we
are progressing AP102 towards clinical trials in 2017."
Enquiries:
Amryt Pharma plc C/o KTZ Communications
Joe Wiley, CEO
Rory Nealon, CFO/COO
Shore Capital +44 (0) 20 7408 4090
Nomad and Joint Broker
Bidhi Bhoma, Edward Mansfield
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
Stifel +44 (0) 20 7710 7600
Joint Broker
Jonathan Senior, Ben Maddison
KTZ Communications +44 (0) 20 3178 6378
Katie Tzouliadis
About Acromegaly
Acromegaly is a rare endocrine disorder that most commonly
results from an adenoma, a benign tumour of the pituitary gland
that secretes excessive growth hormone (GH) and leads to excess
production of the hormone IGF-1. The progression of acromegaly is
typically slow and diagnosis is often delayed by years. As the
disease advances, patients typically exhibit abnormal growth
throughout the body.
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 lead development product, Episalvan, received marketing
approval for the treatment of partial-thickness wounds from the
European Commission in January 2016. Amryt intends to further
develop 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. Amryt is
currently planning a phase III study of Episalvan in EB, which has
been granted US and EU orphan drug designation. The market
opportunity for EB is estimated to be circa US$1.5 billion.
Amryt's earlier stage products are 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. These include 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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