- Oral ferric maltol may offer an alternative treatment option to IV iron even in patients who have failed or not tolerated current oral iron treatments[1]

Amsterdam (ots/PRNewswire) - Norgine B.V. highlighted new data
from a study supported by its partner company Shield Therapeutics,
presented today at the United European Gastroenterology (UEG) Week in
Barcelona showing that ferric maltol, a novel oral iron replacement
therapy, was found to be non-inferior to intravenous (IV) ferric
carboxymaltose (FCM).[1]

Dr. Stefanie Howaldt from the Hamburg Research Institute for IBD,
HaFCED e.K., Germany and Principal Investigator of the study
presented the new research findings during her oral presentation at
UEG Week. Dr. Howaldt said on the importance of the new data for
patients: "We know that ferric maltol is effective with an
established tolerability profile in patients with IBD based on
earlier research but no head-to-head studies between ferric maltol
and IV iron have been conducted so far. The results of this
head-to-head study may facilitate physicians' treatment decisions
enabling them to improve clinical practice and help more patients
with IDA and IBD, in some of whom previous oral iron treatments may
not have worked. Until recently, these patients may have needed IV
administration in hospital but now ferric maltol represents an
alternative oral treatment option."

Iron deficiency anaemia can be a serious complication of IBD
resulting from inflammation, chronic mucosal blood loss and iron
malabsorption. [1] Treatment of IDA involves iron-replacement
therapy often with oral ferrous iron supplementation in the first
instance.[1] However, use of oral ferrous iron medications may be
limited by poor absorption and adverse events [1,2] which can lead
to many unwell patients having to receive IV iron in hospital.

The prospective, multicentre, phase 3b, open-label randomised
controlled study was designed to compare the efficacy and safety of
oral ferric maltol versus IV FCM in the treatment of IDA in adult
patients with IBD.[1]

Patients were randomised to 12 weeks of oral ferric maltol 30 mg
twice daily or IV FCM administered according to standard prescribing
information. Treatment could continue for up to 52 weeks.[1]

The primary endpoint was Hb responder rate defined as the
proportion of patients achieving either a 2 g/dL increase in Hb or
normalisation of Hb (women >=12 g/dL; men >=13 g/dL) at week 12, with
a non-inferiority limit set to 20%. The primary efficacy analysis was
performed for the per protocol (PP) population using observed cases
(OC) approach and supportive analysis was performed for the
intention-to-treat (ITT) population with missing values imputed using
multiple imputation (MI).[1] At 12 weeks, the responder rate of oral
ferric maltol was non-inferior to IV FCM (74% vs 83%, respectively;
20% non-inferiority limit in the PP population). [1]

Notes to Editors:

About IDA in IBD

Iron deficiency anaemia (IDA) is frequently seen in inflammatory
bowel disease (IBD).

Currently, the only treatment option for IDA patients who cannot
tolerate oral iron therapies is IV iron therapy. IV iron therapy,
however, can be time and resource consuming to administer.

In the AEGIS-H2H study, ferric maltol demonstrates increases in
Hb levels that were comparable to IV FCM and now offers an important
alternative option for these patients, maintaining efficacy with good
tolerability, without the need for hospital administration.[3]

About the study

The prospective, multicentre, phase 3b, open-label randomised
controlled trial was designed to compare the efficacy and safety of
oral ferric maltol (FM) and IV ferric carboxymaltose (FCM) in the
treatment of IDA in patients with IBD. The results demonstrated
increases in the mean Hb levels which were non-inferior to IV FCM.[1]

The study included patients aged over 18 years with confirmed IBD
and IDA ([Hb] women 8.0-11.0 g/dL; men 8.0-12.0 g/dL AND either
ferritin <30 ng/mL or ferritin <100 ng/mL with transferrin saturation
<20%). Patients were randomised to 12 weeks of oral FM 30mg twice
daily or IV FCM administered according to standard prescribing
information. Treatment could continue for up to 52 weeks. Efficacy
was assessed in all randomised patients (intention-to-treat [ITT]
population and in patients without serious protocol deviations
(per-protocol population [PP]). The primary endpoint was >=2 g/dL
increase in Hb concentration or normalisation of Hb (women >=12 g/dL;
men >=13 g/dL) at week 12, with a non-inferiority limit set to 20% in
either the ITT or the PP population. The PP population included 178
patients (FM n=86; FCM n=92). At 12 weeks, the PP responder rate was
74% with FM and 83% with FCM in the PP; the difference was therefore
well within the 20% non-inferiority limit (p=0.023). No serious
adverse events related to the study treatment were reported.[1]

About oral ferric maltol (FERACCRU®)

Ferric maltol is a novel oral ferric iron therapy for the
treatment of iron deficiency (ID) in adults. The recommended dose is
one capsule (30mg) taken twice a day, morning and evening, on an
empty stomach. Treatment duration depends on the severity of the iron
deficiency (ID), but generally at least 12 weeks of treatment are
required.[4] For further information, please refer to the product
Summary of Product Characteristics, available at:
https://www.medicines.org.uk/emc/product/2083/smpc.

In the original Phase III AEGIS IBD clinical trial programme,
which led to the license being granted, the efficacy and tolerability
of ferric maltol was assessed in the treatment of IDA in patients
with quiescent or mild-to-moderate IBD versus placebo, who had
previously failed to respond, or had been intolerant to previous oral
ferrous products (OFP). Ferric maltol was shown to be effective and
well-tolerated at both 12 and 64 weeks.[5,6]

About Norgine

Across the globe in 2018, Norgine is proud to have helped 23
million patients and generated EUR395 million in net product sales to
reinvest in medicines for the future, a growth of 15% over 2017.

Norgine is a leading European specialist pharmaceutical company
that has been bringing transformative medicines to patients for over
a century. We understand the complexities of the European healthcare
systems and have a direct presence in 14 European countries, as well
as Australia and New Zealand. We also have a strong global network of
partnerships in non-Norgine markets.

We are a flexible and fully integrated pharmaceutical business,
with manufacturing (Hengoed, Wales and Dreux, France), third party
supply networks and significant product development capabilities, in
addition to our sales and marketing infrastructure. This enables us
to acquire, develop and commercialise specialist and innovative
products that make a real difference to the lives of patients around
the world.

In 2012, Norgine established a complementary business, Norgine
Ventures, supporting innovative healthcare companies through the
provision of debt-like financing in Europe and the US. For more
information, please visit www.norgineventures.com

Follow us on twitter @norgine or visit us at www.norgine.com

NORGINE and the sail logo are trademarks of the Norgine group of
companies.

References

1. Howaldt S, et al. Presented at UEGW 2019, abstract number OP195.
2. Lugg et al. 2014 Journal of Crohn's and Colitis 8, 876-880
3. Shield Study ST10-01-304 Headline Results 4th March 2019: "A phase
3b, randomized, controlled, multicentre study with oral ferric
maltol or intravenous ferric carboxymaltose, for the treatment of
iron deficiency anaemia in subjects with inflammatory bowel
disease"
4. FERACCRU® UK Summary of Product Characteristics, Norgine B.V.
January 2019. Available at:
https://www.medicines.org.uk/emc/product/2083/smpc Accessed
October 2019
5. Gasche C, et al. Inflamm Bowel Dis 2015; 21 (3): 579-588 Available
at https://www.ncbi.nlm.nih.gov/pubmed/25545376 Accessed October
2019
6. Schmidt C, et al. Aliment Pharmacol Ther. 2016 Aug;44(3): 259-270.

GL/COR/1019/0199 , Date of preparation October 2019

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