London - 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), 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 /Accrufer 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 /Accrufer 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/Accrufer 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 /Accrufer on Hb levels over 52 weeks with that of Ferinject (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/Accrufer 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/Accrufer 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.

Contact:

Tim Watts

Tel: +44 (0)20 7186 8500

Web: www.shieldtherapeutics.com

About Shield Therapeutics plc

Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru/Accrufer, a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. Feraccru/Accrufer 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/Accrufer in China, Hong Kong, Macau and Taiwan.

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