Shield Therapeutics PLC AEGIS-H2H study results published in IBD
May 18 2021 - 2:00AM
RNS Non-Regulatory
TIDMSTX
Shield Therapeutics PLC
18 May 2021
Shield Therapeutics plc
("Shield Therapeutics" or the "Company")
AEGIS-H2H study results published in Inflammatory Bowel
Diseases
Study demonstrates long-term effectiveness of ferric maltol
compared to intravenous iron
London, UK, 18 May 2021: 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), notes the recent publication in the journal
Inflammatory Bowel Diseases of positive long-term results from a
study comparing the effectiveness of ferric maltol 30 mg bid with
intravenous (IV) iron (ferric carboxymaltose given according to
each centre's standard practice) over 52 weeks. The primary
endpoint was haemoglobin responder rate (>=2 g/dL increase or
normalization) at week 12, with a 20% noninferiority limit in the
intent-to-treat and per protocol populations.
The open label Phase 3B study included adults with non-severe
active IBD and iron-deficiency anaemia (IDA) and who also had serum
ferritin levels below 30 <MU>g/L or ferritin levels below 100
<MU>g/L and transferrin saturation below 20%. The report of
this first comparative trial, reflecting real-world conditions in
patients with quiescent or mild to moderate IBD and mild to severe
IDA, concluded that both oral ferric maltol and standard regimens
of IV ferric carboxymaltose achieved clinically meaningful
increases in Hb over 12 weeks of treatment, although ferric maltol
did not meet the prespecified noninferiority margin vs IV iron.
Over the longer term, ferric maltol showed comparable efficacy in
maintaining Hb improvements and increasing ferritin up to week 52,
consistent with IV iron. The safety profile of each treatment was
consistent with previous studies.
The publication can be found at
https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izab073/6275616
The lead author, Dr Stephanie Howaldt stated: " Ferric maltol
showed long-term comparable effectiveness in maintaining Hb
improvements and increasing ferritin up to week 52, consistent with
IV iron. The safety profile of each treatment was consistent with
previous studies and mirrors my daily clinical practice. Thus,
ferric maltol offers a simple, well tolerated and cost-effective
long-term treatment solution of chronic IDA in patients with IBD.
"
For further information, please contact:
Shield Therapeutics plc +44 (0) 191 511 8500
Tim Watts (CEO)
Hans-Peter Rudolf (CFO)
Peel Hunt LLP - Nominated Adviser & Joint
Broker +44 (0) 20 7148 8900
James Steel / Christopher Golden
finnCap Ltd - Joint Broker +44 (0) 20 7220 0500
Geoff Nash / Alice Lane/George Dollemore
Walbrook PR - Financial PR & IR Adviser +44 (0) 20 7933 8780
Paul McManus / Lianne Cawthorne or shield@walbrookpr.com
About Shield
Shield is a commercial stage, pharmaceutical company with a
focus on addressing iron deficiency with its lead product Feraccru
(R) /Accrufer (R) (ferric maltol), a novel, stable, non-salt based
oral therapy for adults with iron deficiency with or without
anaemia.
Shield's lead product, 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. The
Group plans to launch Accrufer(R) in the US during 2021 through a
highly experienced sales and marketing team. Feraccru(R) is already
being commercialised in the UK and European Union by Norgine B.V.,
who also have the marketing rights in Australia and New Zealand.
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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