Shield Therapeutics upbeat on latest Feraccru trial results

Commercial stage pharmaceutical company Shield Therapeutics announced positive results from the AEGIS-H2H clinical trial on Monday, which compared ‘Feraccru’ (ferric maltol) - a novel oral iron replacement therapy - to ‘Ferinject’ (ferric carboxymaltose - FCM), the market-leading intravenously delivered iron replacement therapy.

The AIM-traded firm said Feraccru was 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 United States was being reviewed by the FDA, with a Prescription Drug User Fee Act date of 27 July 2019.

Shield said the Feraccru AEGIS-H2H study was a multi-national phase 3b 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 was comparable to the effect seen with FCM treatment at 12 weeks.

That 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 US.

Primary analysis of the AEGIS-H2H study showed 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.

The increase in Hb levels in the Feraccru arm was comparable to that seen in the original AEGIS-IBD study, Shield claimed.

Secondary endpoints included the assessment of Hb response to both therapies, and the 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, would be presented at Shield's upcoming presentation of its preliminary results for 2018, scheduled for early April.

The full data would be submitted for peer-review and subsequent presentation by the study's lead investigators at upcoming scientific meetings, Shield added.

It also said that, after its announcement last September of an exclusive commercialisation agreement with Norgine to commercialise Feraccru in the EU, Australia and New Zealand, Shield would now benefit from a €2.5m milestone payment.

“In a challenging phase 3b clinical study, in which Feraccru has been tested against Ferinject, the standard of care for patients who cannot tolerate or are unwilling to take salt-based oral iron therapies, orally delivered Feraccru has demonstrated it is non-inferior to IV iron therapy in treating iron deficiency anaemia,” said Shield’s chief medical officer Dr Mark Sampson.

“These data enhance the treatment options for such patients as they demonstrate that Feraccru offers a well-tolerated and effective therapy, which can benefit patients in both the short and long term.”

Carl Sterritt, chief executive officer and founder of Shield, added that the company was “delighted” that Feraccru has again performed well in a phase 3 clinical trial, this time delivering a “major achievement” in showing itself to be non-inferior to IV iron therapy, which he said further reinforced the value of Feraccru.

“We are particularly pleased to see such a clinically relevant response to Feraccru throughout the pre-defined assessment timepoints in this complex study, having previously seen very similar long-term benefits in IBD patients with IDA in the AEGIS-IBD study.

“These data provide yet further evidence that Feraccru® is well-tolerated by a majority of treated patients and is effective at correcting both their iron deficiency and anaemia.”