Shield Therapeutics - AEGIS-H2H study reanalysis
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("Shield" or the "Group" or the "Company")
AEGIS-H2H study reanalysis demonstrates that
Feraccru®/Accrufer® is a credible alternative to IV therapy for iron deficiency anaemia
Feraccru®/Accrufer® corrects anaemia and maintains Hb levels over the long term
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
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
The headline results from the reanalysis of the data are as follows:
By week 12 (first phase)
· Of the patients treated with Feraccru®/Accrufer®, 67% of the ITT population and 68% of the PP population had responded to treatment as defined above. In the IV arm, 84% of the ITT population and 85% of the PP population had responded meaning that Feraccru®/Accrufer® did not achieve non-inferiority at 12 weeks in the primary endpoint in either population.
· The mean increase in Hb levels per patient in the Feraccru®/Accrufer® arm was clinically significant at 2.45 g/dL for the ITT population and 2.57 g/dL in the PP population, compared with 3.04 g/dL and 3.05 g/dL respectively for IV-treated patients.
Long term phase (using the ITT results)
· By week 24, 65% Feraccru®/Accrufer® of those patients still being monitored had achieved normal levels of Hb(2) and therefore were non-anaemic, compared with 68% of IV patients.
· At weeks 24, 36 and 52, the mean increases in Hb levels in those patients still being monitored were 2.93 g/dL, 3.16 g/dL and 2.72 g/dL in the Feraccru®/Accrufer® arm compared with 2.84 g/dL, 2.70 g/dL and 2.79 g/dL in the IV arm.
Health economics benefits
During the first 12-week phase of the study, 82% of IV patients received more than one infusion and collectively 138 days were taken off work in this phase. In the extension phase from week 13 to week 52, 47% of patients
Shield plans to publish the full AEGIS-H2H study results in a peer-reviewed paper in due course.
Dr Stephanie Howaldt, one of the study investigators and a co-author of the ECCO abstract, commented on the reanalysis of these results, saying: "In my daily clinical practice, I am looking for an effective, easy to use, well tolerated and cost-efficient long-term therapeutic approach treating patients with IDA. This analysis showed clinical meaningful responses with both ferric carboxymaltose and ferric maltol after 4 weeks and the results are consistent with the ferric maltol pivotal Phase III study programme. Most importantly, ferric maltol demonstrated comparable effectiveness at maintaining Hb and iron status for up to 52 weeks, preventing relapse, which was seen frequently in the ferric carboxymaltose group, requiring additional IV therapy. Ferric maltol is therefore an appropriate cost-effective alternative to IV iron especially for long-term treatment of IDA in IBD."
Note 1 - The ITT population refers to all patients
Note 2 - Normal levels of Hb are defined by the
Note 3 - ECCO abstract EC20-0754 "Health care resource use associated with ferric maltol and IV iron treatment for iron deficiency anaemia in patients with Inflammatory Bowel Disease" https://www.ecco-ibd.eu/publications/congress-abstracts/item/p685-healthcare-resource-use-associated-with-ferric-maltol-and-iv-iron-treatment-for-iron-deficiency-anaemia-in-patients-with-inflammatory-bowel-disease.html
For further information please contact:
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+44 (0)20 7186 8500
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Nominated Adviser and Joint Broker
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+44 (0)20 7418 8900
+44 (0)20 7220 0500
Financial PR & IR Advisor
+44 (0)20 7933 8780 or [email protected]
Paul McManus/Lianne Cawthorne
+44 (0)7980 541 893 / +44 (0)7584 391 303
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,
For more information, please visit www.shieldtherapeutics.com. Follow Shield on Twitter @ShieldTx
This information is provided by RNS, the news service of the
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