TIDMSTX
RNS Number : 3992V
Shield Therapeutics PLC
06 August 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 reanalysis demonstrates that
Feraccru(R)/Accrufer(R) is a credible alternative to IV therapy
for iron deficiency anaemia
Feraccru(R)/Accrufer(R) corrects anaemia and maintains Hb levels
over the long term
London, UK, 6 August 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), provides the headline results from the reanalysis
of the AEGIS-H2H study .
The AEGIS-H2H study was intended and designed to provide data
comparing oral Feraccru (R) /Accrufer (R) against intravenous (IV)
iron therapy from which health economics data and other analysis
could be generated. The study was not intended as a registration
study and the regulatory status of Feraccru (R) /Accrufer (R) is
unaffected by the study. On 17 March 2020 Shield announced an
update and clarification relating to the original results of the
AEGIS-H2H study (announced in March 2019) and that the Board had
instigated a thorough and complete review into the analysis. This
review has now been completed, including an independent statistical
review.
The Feraccru(R)/Accrufer(R) AEGIS-H2H study was a multi-national
Phase IIIb randomised study in 250 inflammatory bowel disease (IBD)
patients with mild to severe iron deficiency anaemia (IDA) and
baseline haemoglobin (Hb) measurements at the start of the study as
low as 8.0g/dL. The main objectives of the study were to compare
the
impact of Feraccru (R) /Accrufer (R) on Hb levels over 52 weeks with that of Ferinject(R) (ferric carboxymaltose (FCM)), the market-leading intravenously (IV) delivered iron replacement therapy treatment. Patients were monitored 5 times during the course of the study, at weeks 4, 12, 24, 36 and 52. Reflecting clinical practice, IV FCM was administered in the study according to each physician's local prescribing information which allow, in some participating countries, for multiple additional IV dosing whereas Feraccru(R)/Accrufer(R) could only be given 30 mg twice daily in line with the US and European approved label.
The first 12-week phase compared the initial Hb response in
patients, with a "response" defined for the purpose of the primary
endpoint as the normalisation of Hb levels or an increase of at
least 2g/dL in Hb from patients' baseline levels. The primary
endpoint of the study was defined as achieving non-inferiority in
the proportion of responders in both the "intention to treat"
(ITT)(1) and "per protocol" (PP)(1) populations at the end of the
initial 12 weeks. The March 2020 RNS clarified that the study had
not met this 12-week primary endpoint. The initial 12-week period
was followed by a 40-week extension phase, during which patients
continued treatment with Feraccru(R)/Accrufer(R) or received
further IV iron infusions in line with clinical need. The purpose
of this second phase was to understand how well each therapy
maintained Hb levels and corrected anaemia and to enable
evaluations of health economic outcomes. For health economics
analysis, the ITT population is preferred as this is considered to
be closer to real world experience than the PP population.
The headline results from the reanalysis of the data are as
follows:
By week 12 (first phase)
-- Of the patients treated with Feraccru (R) /Accrufer (R), 67%
of the ITT population and 68% of the PP population had responded to
treatment as defined above. In the IV arm, 84% of the ITT
population and 85% of the PP population had responded meaning that
Feraccru (R) /Accrufer (R) did not achieve non-inferiority at 12
weeks in the primary endpoint in either population.
-- The mean increase in Hb levels per patient in the Feraccru
(R) /Accrufer (R) arm was clinically significant at 2.45 g/dL for
the ITT population and 2.57 g/dL in the PP population, compared
with 3.04 g/dL and 3.05 g/dL respectively for IV-treated
patients.
Long term phase (using the ITT results)
-- By week 24, 65% Feraccru (R) /Accrufer (R) of those patients
still being monitored had achieved normal levels of Hb(2) and
therefore were non-anaemic, compared with 68% of IV patients.
-- At weeks 24, 36 and 52, the mean increases in Hb levels in
those patients still being monitored were 2.93 g/dL, 3.16 g/dL and
2.72 g/dL in the Feraccru (R) /Accrufer (R) arm compared with 2.84
g/dL, 2.70 g/dL and 2.79 g/dL in the IV arm.
Health economics benefits
During the first 12-week phase of the study, 82% of IV patients
received more than one infusion and collectively 138 days were
taken off work in this phase. In the extension phase from week 13
to week 52, 47% of patients who were monitored after the week 12
visit required at least one further infusion. The health economic
outcomes from these results, and other more detailed results from
the study, are broadly unchanged from the original 2019 analysis
and demonstrate that Feraccru (R) /Accrufer (R) compares favourably
with IV therapy . For example, in an abstract(3) published at the
European Crohn's and Colitis Organisation (ECCO) congress in
February 2020, the authors concluded that the "mean total
per-patient drug costs (acquisition + administration) were
approximately 1.6 times higher for treatment with IV FCM than
ferric maltol, when modelled for a German healthcare setting. The
higher cost of IV FCM is driven by higher drug cost and costs of IV
administration. As an oral treatment ferric maltol has no
administration-related costs or resource use, thus reducing the
burden on payers and local health care services."
Shield plans to publish the full AEGIS-H2H study results in a
peer-reviewed paper in due course.
Dr Stephanie Howaldt, one of the study investigators and a
co-author of the ECCO abstract, commented on the reanalysis of
these results, saying: "In my daily clinical practice, I am looking
for an effective, easy to use, well tolerated and cost-efficient
long-term therapeutic approach treating patients with IDA. This
analysis showed clinical meaningful responses with both ferric
carboxymaltose and ferric maltol after 4 weeks and the results are
consistent with the ferric maltol pivotal Phase III study
programme. Most importantly, ferric maltol demonstrated comparable
effectiveness at maintaining Hb and iron status for up to 52 weeks,
preventing relapse, which was seen frequently in the ferric
carboxymaltose group, requiring additional IV therapy. Ferric
maltol is therefore an appropriate cost-effective alternative to IV
iron especially for long-term treatment of IDA in IBD."
Tim Watts, CEO of Shield Therapeutics also commented, saying:
"We are very pleased that the reanalysis of the AEGIS-H2H study
data demonstrates that Feraccru(R)/Accrufer(R) is a credible
alternative to IV therapy and offers economic advantages. Having
resolved the anomalies seen in the original analysis the study
results can now be used with confidence for further health
economics analysis and to support pricing and reimbursement
applications in Europe."
Note 1 - The ITT population refers to all patients who were
randomised into the study, whether or not they completed the study
in compliance with the study design. The PP population includes
only those patients who completed each phase of the study in
accordance with the study design.
Note 2 - Normal levels of Hb are defined by the World Health
Organisation as 12 g/dL for women and 13 g/dL for men
Note 3 - ECCO abstract EC20-0754 "Health care resource use
associated with ferric maltol and IV iron treatment for iron
deficiency anaemia in patients with Inflammatory Bowel Disease"
https://www.ecco-ibd.eu/publications/congress-abstracts/item/p685-healthcare-resource-use-associated-with-ferric-maltol-and-iv-iron-treatment-for-iron-deficiency-anaemia-in-patients-with-inflammatory-bowel-disease.html
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Tim Watts, CEO +44 (0)20 7186 8500
Karen Chandler Smith, Investor
Relations
Nominated Adviser and Joint
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
+44 (0)7980 541 893 / +44 (0)7584 391
Paul McManus/Lianne Cawthorne 303
About Shield Therapeutics plc
Shield is a de-risked, specialty pharmaceutical company focused
on commercialising its lead product, Feraccru(R)/Accrufer(R), a
novel, stable, non-salt based oral therapy for adults with iron
deficiency with or without anaemia. Feraccru(R)/Accrufer(R) has
been approved for use in the United States, European Union, UK and
Switzerland and has exclusive IP rights until the mid-2030s.
Feraccru is commercialised in the UK and Europe by Norgine B.V. and
the Company is currently in the process of selecting a
commercialisation partner for the US market. 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 .
Follow Shield on Twitter @ShieldTx
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END
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