Positive results from the AEGIS-H2H trial which compared treatments of iron deficiency

Shield Therapeutics plc announces positive results from the AEGIS-H2H clinical trial which compared Feraccru (ferric maltol), a novel oral iron replacement therapy, to Ferinject (ferric carboxymaltose (FCM)), the market-leading intravenously delivered iron replacement therapy. Feraccru is approved and marketed in the European Union for the treatment of iron deficiency (ID) in adults and in Switzerland for the treatment of iron deficiency anaemia (IDA) in adults with inflammatory bowel disease (IBD). A New Drug Application in the USA is being reviewed by the FDA with a PDUFA date of 27 July 2019.

The Feraccru AEGIS-H2H study was a multi-national Phase IIIb randomised, active-controlled trial in 242 IBD patients with IDA and haemoglobin (Hb) measurements as low as 8.0g/dL. The objective of the study was to assess whether the effect of Feraccru on Hb response (defined by the protocol as normalisation of Hb or a >2g/dL rise in Hb from baseline) was comparable to the effect seen with FCM treatment at 12 weeks. This was followed by a 40- week extension phase, during which eligible subjects continued treatment with Feraccru or received FCM in line with clinical need as described in FCM’s Summary of Product Characteristics in the EU and its Prescribing Information in the USA. Primary analysis of the AEGIS-H2H study has shown that response to Feraccru at 12 weeks was within 9% of the response seen with FCM and within the 20% limit required by the study protocol to confirm non-inferiority (p = 0.022). The increase in Hb levels in the Feraccru arm was comparable to that seen in the original AEGIS-IBD study. Secondary endpoints included assessment of Hb response to both therapies and measurement of key iron storage parameters through 52 weeks as well as the usual safety assessments. More detailed analyses of the data, including the secondary endpoints and safety parameters, will be presented at Shield’s upcoming presentation of its preliminary results for 2018, scheduled for early April 2019, whilst the full data will be submitted for peer-review and subsequent presentation by the study’s lead investigators at upcoming scientific meetings.

Further to the announcement in September 2018 of an exclusive commercialisation agreement with Norgine B.V. to commercialise Feraccru in the EU, Australia and New Zealand, the Company will now benefit from a €2.5 million milestone payment.

Comment: Feraccru offers a simple, well tolerated and efficacious oral treatment alternative to IV iron therapy without the need for hospital-based administration.