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Shield Therapeutics’ ST10 Delivers Robust Results Meeting both Primary and Secondary Endpoints in the Pivotal AEGIS Phase 3 Programme for the Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease

January 7, 2014

LONDON, January 7, 2014 /PRNewswire/ –

~ ST10 strongly demonstrates potential to be (1) the only effective oral

treatment for ferrous intolerant IDA patients and (2) an effective alternative to

intravenous iron treatment ~

Shield Therapeutics (Shield), an independent specialty pharmaceutical company focused
on the development of mineral-derived hospital pharmaceuticals, today announces strongly
positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of
iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD).

ST10, a novel orally-dosed form of ferric iron, delivered a mean improvement in
haemoglobin levels of 2.3g/dL (p <0.0001), clearly meeting the primary endpoint of
haemoglobin change after 12 weeks’ treatment compared to placebo. More than 65% of treated
subjects experienced normalised haemoglobin levels by week 12 and ST10 also rapidly
delivered significant improvements in haemoglobin at 4 weeks (1.1g/dL, p <0.0001) and 8
weeks (1.8g/dL, p <0.0001) of therapy. From a safety perspective, ST10 did not adversely
affect IBD symptoms in treated subjects and was well tolerated for the duration of
exposure.

The two AEGIS protocols recruited 128 patients with anaemia secondary to either
Crohn’s disease or ulcerative colitis who had previously failed therapy with oral ferrous
products due to intolerance and/or inadequate therapeutic benefit. Patients were recruited
from expert centres in Austria, Germany, Hungary and the UK and were randomised (1:1) to
receive ST10 or a matched placebo capsule. Other iron therapies were not permitted during
the study. Adverse events recorded during the study were mainly gastrointestinal in nature
and occurred in the ST10-treated arm with placebo-like frequency (38% of ST10-treated
subjects and 40% of placebo-treated subjects). Withdrawal from the study before 12 weeks
(due to adverse events or subject decision) occurred in seven ST10-treated and nine
placebo-treated subjects. Patients who completed the 12-week double-blind phase of the
study continued treatment in a 12-month open-label extension phase and results of this
will be available later this year.

These results provide confirmatory pivotal clinical data which will form the basis of
a Marketing Authorisation Application submission to the European regulatory authorities
during 2014. In conjunction with data that will be generated from the study of ST10 in the
treatment of IDA in pre-dialysis chronic kidney disease patients that is currently
progressing, these results will also form part of a subsequent New Drug Application
submission to the FDA in the USA.

Full findings from the AEGIS studies will be presented at scientific congresses in due
course.

Commenting on the results, Professor Christoph Gasche, Professor of Medicine, Medical
University of Vienna, Austria, said:

“I have studied the problem of anaemia in inflammatory bowel disease (IBD) patients
for many years, and the data from the AEGIS studies are very encouraging. Until now there
has been no acceptable oral iron treatment available for the majority of my IBD patients
with iron deficiency anaemia. These results are statistically very convincing and the 2.3
g/dL rise in haemoglobin at 12 weeks together with the more than 1.1g/dL rise in
haemoglobin at 4 weeks compared to placebo are clinically meaningful for anaemic patients.
The safety results from this study also show that ST10 is well tolerated with just a very
small number of subjects withdrawing because of adverse effects and the frequency of GI
side effects was similar in the placebo and ST10 groups. My personal experience of the
patients that I treated in this study fits with these results.”

Also commenting on the results, Dr Tariq Ahmad, Consultant Gastroenterologist at the
Royal Devon and Exeter Foundation Trust, Exeter, UK, said:

“Iron deficiency anaemia is a real problem for many of my patients. Unfortunately
patients often struggle with GI side effects caused by conventional ferrous iron salts.
Currently we offer such patients intravenous iron in hospital. This is costly to
administer, inconvenient for patients and associated with a small but significant risk of
anaphylaxis. The exciting AEGIS Phase 3 data suggests that ST10 will provide an effective,
safe and more convenient alternative to intravenous iron for this group of patients as
demonstrated by ST10 keeping our patients out of the infusion room by correcting and
maintaining their haemoglobin in the normal range.”

Shield’s Founder and Chief Executive Officer, Carl Sterritt, commented:

“Delivering such resoundingly positive findings from these pivotal trials of ST10 in
IBD is a tremendous achievement for Shield; and the whole team is indebted to the patients
and investigators who participated in the protocols. Our next aim is to make this therapy
available as quickly as possible on a commercial basis to as wide an audience of
prescribers and patients as we can, so we will be working diligently with regulatory
authorities to achieve this goal.

“The results reflect an important milestone in the development of ST10 as the only
effective, low-dose oral iron-replacement therapy without the significant GI side-effects
of ferrous iron or the high risks associated with intravenous administration of iron. ST10
presents a significant opportunity for Shield to develop a paradigm changing treatment
that will address a broad range of indications with a strong commercial potential and we
look forward to rapidly advancing the programme.”

About Shield Therapeutics

Shield Therapeutics (http://www.shieldtherapeutics.com), founded in 2008, is an
independent specialty pharmaceutical company focused on the development and
commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address
areas of high unmet medical need. Shield has successfully completed a pivotal Phase 3
programme of its lead asset, ST10, for the treatment of iron deficiency anaemia associated
with inflammatory bowel disease and is soon to commence a Phase 3 study of ST10 for the
treatment of iron deficiency anaemia in patients with chronic kidney disease.

        For more information about Shield Therapeutics, please contact:

        Shield Therapeutics
        Carl Sterritt, Chief Executive Officer
        Tel +44(0)20-7186-0360

        Consilium Strategic Communications
        Mary-Jane Elliott / Emma Thompson / Lindsey Neville
        Tel +44(0)20-7920-2333

        Email: shieldtherapeutics@consilium-comms.com

SOURCE Shield Therapeutics


Source: PR Newswire



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