Shield Therapeutics PLC AEGIS-CKD study results published in AJKD
09 Agosto 2021 - 1:00AM
RNS Non-Regulatory
TIDMSTX
Shield Therapeutics PLC
09 August 2021
Shield Therapeutics plc
("Shield or the "Company" or the "Group")
AEGIS-CKD study results published in American Journal of Kidney
Disease
Ferric maltol demonstrates statistically significant (16 weeks)
and sustained (up to 52 weeks) increase in haemoglobin, compared to
placebo, in subjects with chronic kidney disease (CKD) and iron
deficiency
anaemia (ID)
London, UK, 9 August 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 on-line publication in the
American Journal of Kidney Disease showing positive 16 week and
long-term results from a study comparing the effectiveness of
ferric maltol 30 mg bid with placebo over 16 weeks (2:1
randomization), and long-term up to 52 weeks. The primary endpoint
was change from baseline in haemoglobin at week 16.
The double-blind randomised placebo-controlled Phase 3 study
included adults with stage 3/4 CKD and mild to moderate
iron-deficiency anaemia (IDA), who also had serum ferritin levels
below 250 <MU>g/L and transferrin saturation below 25% or
ferritin levels below 500 <MU>g/L and transferrin saturation
below 15%. The paper concluded that the AEGIS-CKD trial shows that
oral ferric maltol raises and sustains haemoglobin to provide iron
for erythropoiesis in patients with eGFR as low as 30 mL/min/1.73
m2. Further, ferric maltol provides significant and sustained
increases in iron storage indices, providing long-term control of
IDA. In this population, ferric maltol was generally well
tolerated, with a low rate of discontinuation due to adverse
events. A drug such as ferric maltol that is able to replace and
restore iron, that is orally administered, and that patients are
able to tolerate will provide a clinically relevant treatment
option for patients with moderate to severe CKD and anaemia due to
iron deficiency
The publication can be found at
https://pubmed.ncbi.nlm.nih.gov/34029682/
The lead author, Dr Nelson Kopyt stated: "Iron deficiency
anaemia is a common problem that we must deal with in our CKD
patients. With the data from this study we now have very good
evidence that oral ferric maltol is well tolerated and results in a
statistically significant and sustained increase in haemoglobin for
the 52 weeks studied. This is very exciting news as we now have an
iron preparation that can be administered orally with patient
tolerability comparable to placebo."
For further information, please contact:
Shield Therapeutics plc +44 (0) 191 511 8500
Greg Madison (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/ Alice or shield@walbrookpr.com
Woodings
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,
Switzerland and Australia and has exclusive IP rights until the
mid-2030s. The Group is currently launching Accrufer(R) in the US.
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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