AEGIS-CKD study results published in AJKD

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®/Accrufer® (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 μg/L and transferrin saturation below 25% or ferritin levels below 500 μg/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."

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About Shield

Shield is a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru ® /Accrufer ® (ferric maltol), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia.

Shield's lead product, Feraccru®/Accrufer®, 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® in the US. Feraccru® 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®/Accrufer® in China, Hong Kong, Macau and Taiwan. 

For more information, please visit www.shieldtherapeutics.com. Follow Shield on Twitter @ShieldTx