TIDMSTX
RNS Number : 3736G
Shield Therapeutics PLC
17 March 2020
The information contained within this announcement is deemed by
the Group to constitute inside information as stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public domain
Shield Therapeutics plc
("Shield" or the "Group" or the "Company")
AEGIS-H2H study update
London, UK, 17 March 2020: Shield Therapeutics plc (LSE: STX), a
commercial stage, pharmaceutical company with a focus on addressing
iron deficiency with its lead product Feraccru (R) /Accrufer (R)
(ferric maltol), a novel oral iron treatment, today provides an
update and clarification relating to the AEGIS-H2H clinical trial,
the data from which was primarily designed to be used in health
economic analyses, pricing and reimbursement applications as well
as marketing purposes.
This update has no impact on existing marketing authorisations
in the EU, US and Switzerland, nor on any approved prescribing
information and the data from this AEGIS-H2H study has not been
used in any of the regulatory submissions that have led to the
approval of Feraccru (R) /Accrufer (R) in either Europe, the USA or
Switzerland .
Based on a range of positive clinical trials Feraccru (R)
/Accrufer (R) is approved for the treatment of iron deficiency in
adults with or without anaemia in the USA, the European Union and
Switzerland. Commercial partners including Norgine BV and Beijing
Aosaikang Pharmaceutical Co. Ltd have licensed the rights to
Feraccru (R) /Accrufer (R) in the European Union, Australia, New
Zealand and China and a partnering process for the commercial
rights to Feraccru (R) /Accrufer (R) in the USA is also currently
being conducted with the Company continuing to work diligently
towards the appointment of a suitable commercial partner.
On 4 March 2019 Shield announced that the AEGIS-H2H clinical
trial had delivered positive results, demonstrating that Feraccru
(R) /Accrufer (R) is non-inferior to a market-leading intravenous
(IV) iron therapy in treating iron deficiency anaemia in adults
with inflammatory bowel disease (IBD). The announcement stated that
primary analysis of the AEGIS-H2H study demonstrated the response
to Feraccru (R) /Accrufer (R) at 12 weeks was within 9% of the
response seen with the IV iron therapy and within the 20% limit
required by the study protocol to confirm non-inferiority (p =
0.022, subsequently adjusted to p = 0.017 after detailed
analysis).
The above statement was made in relation to the "per protocol"
(PP) analysis of the study results. These data have been published
and presented at both the United European Gastroenterology Week
(UEGW)(1) and European Crohn's and Colitis Organisation (ECCO)(2)
scientific congresses. The PP analysis refers to those patients who
fully complied with the study design and remained on the study for
the full 12-week period, at the end of which the primary end point
was measured. With an open-label design, as was used in this study,
the true efficacy of the different oral and intravenous treatment
arms is better determined by using the PP population, which
accounts for low compliance and early withdrawal, whereas the
"intention to treat" (ITT) population is liable to overestimate the
adverse events and underestimate the efficacy of the oral agent as
these are given via daily administration, whereas the comparator is
administered as a bolus dose. The International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) advises caution in the use of ITT analyses in
non-inferiority trials(3) . Therefore, it was decided to use the PP
population for the primary efficacy analysis.
However, the pre-defined success criteria of this clinical
study, as set out in the statistical analysis plan, inadvertently
required that ferric maltol could be considered non-inferior to IV
iron if the difference in the proportion of responders in each arm
at week 12 was less than 20% in both the ITT and the PP analyses,
but should have allowed for non-inferiority if either the PP or ITT
populations achieved this target. In the ITT analysis (which refers
to all patients who were randomised into the study, whether or not
they completed the entire 12-week period and fully complied with
the study design), Feraccru (R) /Accrufer (R) clearly demonstrated
effectiveness, but did not achieve non-inferiority compared to the
IV iron therapy. The 4 March 2019 announcement should therefore
have made it clear that the study did not achieve non-inferiority
in both of the ITT and PP analyses.
In light of the above finding which has just come to light, the
Board has instigated an immediate independent review into the
analysis of both datasets, which is being overseen by a
non-executive director. The Company will update the market on this
review in due course.
As stated above, this clarification has no impact on existing
marketing authorisations, nor on any approved prescribing
information and the data was not used in the regulatory submissions
that led to the approval of Feraccru (R) /Accrufer (R) in either
Europe, the USA or Switzerland. Shield remains confident that data
from the AEGIS-H2H study including the long term extension results,
together with the existing positive efficacy and safety data on the
product provide compelling evidence that Feraccru (R) /Accrufer (R)
is an important treatment alternative for many patients, combining
efficacy with good tolerability, without the need for hospital
administration .
In the meantime, the Company is working closely with its
commercial partners to ensure relevant information is clearly
communicated to all stakeholders in a timely manner.
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Carl Sterritt, Chief Executive
Officer +44 (0)20 7186 8500
Tim Watts, Chief Financial
Officer
Nominated Advisor and Broker
Peel Hunt LLP
James Steel/Dr Christopher
Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/Matt Radley/Alice
Lane +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR +44 (0)20 7933 8780 or shield@walbrookpr.com
Paul McManus +44 (0)7980 541 893
About Shield Therapeutics plc
Shield is a de-risked, commercial stage, specialty
pharmaceutical company delivering innovative pharmaceuticals to
address patients' unmet medical needs. The Company's clear purpose
is to develop products that help patients become people again,
enabling them to enjoy the things that make a difference in their
everyday lives . The Group's lead product, Feraccru (R) / Accrufer
(R) has exclusive IP rights until the mid-2030s and is approved for
the treatment of iron deficiency with or without anaemia in adults
in the European Union, the United States and Switzerland. In Europe
it is marketed as Feraccru (R) with commercialisation led by
Norgine BV and in the USA the product will be marketed as Accrufer
(R) with Shield currently in the process of selecting a
commercialisation partner. Shield also has an exclusive licence
agreement with Beijing Aosaikang Pharmaceutical Co. Ltd for the
development and commercialisation of Feraccru(R)/Accrufer(R) in
China, Hong Kong, Macau and Taiwan. For more information please
visit www.shieldtherapeutics.com
About Feraccru(R)/Accrufer(R)
Feraccru (R) /Accrufer(R) is a novel, stable, non-salt based
oral therapy for adults with iron deficiency with or without
anaemia that has been shown to be an efficacious and well-tolerated
therapy in a range of controlled phase 3 trials, and offers a
compelling alternative to IV iron for those patients unable to
tolerate salt-based oral iron therapies and wish to avoid the
complexities of infusion-based iron therapies.
When salt-based oral iron therapies are ingested they can cause
a range of mild-to-severe gastrointestinal tract (GI) adverse
events, including nausea, bloating and constipation through the
release and subsequent reactivity of free iron in the GI tract,
leading to poor tolerability, reduced patient compliance and
ultimately treatment failure. Feraccru (R) /Accrufer(R) is not an
iron salt and, as a result, it does not routinely cause the same
treatment-limiting intolerance issues of salt-based iron therapies,
whilst the iron from the ferric maltol molecule can be readily
absorbed.
Prior to Feraccru (R) /Accrufer(R) , IV iron therapies were the
only realistic alternative treatment option for iron deficient
patients with or without anaemia intolerant of or unwilling to be
treated salt-based oral iron therapies. However, use of such an
invasive, costly, inconvenient and complex to administer treatment
option, which is associated with potentially life-threatening and
spontaneous hypersensitivity reactions, means there remains a clear
unmet medical need for these patients to have access to an
effective therapy that is well tolerated, convenient and does not
require hospital-based administration. Feraccru (R) /Accrufer(R)
meets those requirements.
About Iron Deficiency
The WHO states that iron deficiency is the most common and
widespread nutritional disorder in the world. As well as affecting
a large number of women and children in non-industrialized
countries, it is the only nutrient deficiency which is also
significantly prevalent in virtually all industrialised 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-industrialised
countries, together with at least 30-40% in industrialized
countries, are iron deficient.
Footnotes
1. Howaldt S et al. OP195. UEG Journal. 2019 Vol. 7(8S):106
Doi:10.1177/2050640619854663
2. Howaldt S, et al. P685, presented at ECCO 2020; Howaldt S, et
al. P331, presented at ECCO 2020, Howaldt S, et al. P567, presented
at ECCO 2020
3. European Medicines Agency. ICH Topic E 9 Statistical
Principles for Clinical Trials. CPMP/ICH/363/96. September
1998.
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