TIDMSTX
RNS Number : 3392R
Shield Therapeutics PLC
14 June 2018
Shield Therapeutics plc
("Shield" or the "Group")
Shield reports positive top-line results from its AEGIS-PAED PK
Paediatric Phase I Pharmacokinetics study of Feraccru(R) (Ferric
Maltol) in subjects with iron deficiency
London, UK, 14 June 2018: Shield Therapeutics plc (LSE:STX), a
commercial stage, pharmaceutical company delivering innovative
specialty pharmaceuticals to address patients' unmet medical needs,
today announces top line results from its paediatric phase I
pharmacokinetics (PK) study of Feraccru in 36 subjects aged 12-17
years. Feraccru is a novel oral ferric iron therapy that is
approved and marketed in Europe for the treatment of iron
deficiency (ID).
The Feraccru AEGIS-PAED PK study is a Phase I trial with a
primary endpoint of evaluating the iron response to, and safety of,
Feraccru at different doses in adolescent subjects aged 12 -17
years with ID. Completion of this study signifies delivery of the
first major milestone in Feraccru's paediatric development plan as
agreed with the EMA. These data allow for selection of an optimal
dosing schedule for a Phase III pivotal study in children that will
follow subject to funding.
Positive results from the Phase III study should lead to
Feraccru being granted a paediatric license, thus providing an even
larger commercial opportunity for this effective therapy in the
treatment of ID.
Preliminary results:
Feraccru achieved all the pre-defined goals of the protocol,
including demonstrating positive effects on serum iron parameters
over the duration of the study and showing good tolerance at all
dosing levels.
Dr Stephen Allan, Professor of Paediatrics, Liverpool School of
Tropical Medicine, UK commented, : "Iron deficiency is a global
problem in children that significantly impacts their health and
education and leads to longer term societal impact. There is a
great need for a widely available oral therapy that is both
effective and well tolerated. These results are encouraging and I
look forward to the results of the Phase III study."
Mark Sampson, Chief Medical Officer at Shield Therapeutics
stated "I am delighted that these results confirm the potential of
Feraccru to provide a well-tolerated and effective oral therapy for
children suffering with iron deficiency and allows us to progress
to our pivotal Phase III programme. We are grateful to the children
and parents who were willing to participate in the study and
progress our knowledge of Feraccru."
About Feraccru(R)
Feraccru is a novel, stable, non-salt, oral formulation of
ferric iron, which has a differentiated mechanism of action
compared to salt-based oral iron therapies. When salt-based oral
iron therapies are ingested, the iron must dissociate from the salt
in the GI tract to allow the iron to be absorbed and treat the ID.
This free iron readily chelates to form insoluble clumps and
produces damaging free radicals that together cause a range of
mild-to-severe GI adverse events, including nausea, bloating and
constipation, leading to poor tolerability, reduced patient
compliance and ultimately treatment failure. In addition, many
patients with ID are concurrently treated with medicines that raise
the pH in the gut which further reduces the effect of salt-based
oral iron therapies as they require highly acidic conditions to be
absorbed.
Feraccru is not an iron salt, and iron can be absorbed from the
ferric maltol molecule, as a result, it does not routinely cause
the same treatment-limiting intolerance issues. Feraccru has been
shown in clinical trials to be well-tolerated by patients even when
they had previously failed treatment with salt-based oral iron
therapies, which should lead to increased patient compliance and
better patient outcomes.
Currently, the only treatment option for ID patients who cannot
tolerate salt-based oral iron therapies, is IV iron therapy. IV
iron therapies quickly increase iron stores via direct
administration of high doses of iron causing an increase in Hb
levels that is physiologically controlled and occurs over a period
of weeks, as is the case with Feraccru. IV iron therapies, however,
are invasive, costly, inconvenient and complex to administer, and
also come with potentially life-threatening, spontaneous
hypersensitivity reactions.
About Iron Deficiency
The WHO state that iron deficiency is the most common and
widespread nutritional disorder in the world. As well as affecting
a large number of children and women in non-industrialized
countries, it is the only nutrient deficiency which is also
significantly prevalent in virtually all industrialized nations.
There are no current global figures for iron deficiency, but using
anaemia as an indirect indicator it can be estimated that most
preschool children and pregnant women in non-industrialized
countries, and at least 30-40% in industrialized countries, are
iron deficient.
Other Feraccru pipeline events:
Feraccru AEGIS-H2H non-inferiority EU Phase 3b study
The AEGIS-H2H Phase 3b study is designed as a non-inferiority
trial comparing the efficacy and safety of Feraccru to the
market-leading latest generation form of IV iron
(Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint
data from the AEGIS-H2H study is expected to be available in the
second half of 2018.
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Dr Karl Keegan, Chief Financial Officer
Nominated Advisor and Joint Broker +44 (0)203 100 2222
Liberum Capital Limited
Christopher Britton/Steve Pearce
Joint Broker +44 (0)207 418 8900
Peel Hunt LLP
James Steel/ Dr Christopher Golden
Financial PR Advisor +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
US Investor Relations +1 (212) 867 1762
Lazar Partners
Fern Lazar/David Carey
About Shield Therapeutics plc
Shield is a commercial stage, pharmaceutical company delivering
innovative specialty pharmaceuticals to address patients' unmet
medical needs. Our clear purpose is to help our patients become
people again, by enabling them to enjoy the things that make the
difference in their everyday lives. The Group has a marketed
product, Feraccru(R), for the treatment of ID in adult patients
which has exclusive IP rights until the mid-2030's. For more
information please visit www.shieldtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements. These forward-looking statements are based on
management's current expectations and include statements related to
the timing of future results of Feraccru trials and the timing and
success of the Group's regulatory plans and commercial strategy for
Feraccru. These statements are neither promises nor guarantees, but
involve known and unknown risks and uncertainties, many of which
are beyond our control, that may cause actual results, performance
or achievements to be materially different from management's
expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with
the regulatory approval process, the Group's business and results
of operations, competition and other market factors. The
forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and
except as required by law, the Group disclaims any obligation to
update any forward-looking statements contained in this release,
even if subsequent events cause our views to change.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
RESEANKDFDAPEFF
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