REG - Shield Therapeutics - Data published -European Journal of Heart Failure

Shield TherapeuticsAnnouncement

27/08/2025 07:15

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RNS Number : 8365W  Shield Therapeutics PLC  27 August 2025

  Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

Positive efficacy and safety results in subjects with Heart Failure (HF) and
Iron Deficiency Anemia (IDA) treated with ACCRUFeR®/FeRACCRU® (ferric
maltol)

 

Data recently published in the European Journal of Heart Failure

 

London, UK, August 27, 2025: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces positive efficacy and safety results in the ORION-HF study showing
improvements in haemoglobin and other iron markers, exercise capacity, and
quality of life (QoL) in patients with heart failure (HF) and iron deficiency
anemia (IDA), after 16 weeks of treatment with FeRACCRU® (ferric maltol).
 These results were published in the European Journal of Heart Failure on 21
July 2025.

 

The ORION-HF study was a multicenter, European, open-label, prospective
clinical study, to investigate the impact of orally formulated ferric maltol
(30 mg bid) in 50 patients with symptomatic HF and IDA.

 

Positive and clinically meaningful efficacy and safety results were achieved
in the study:

·    Significant increase in haemoglobin (Hb) concentration (Primary
endpoint): Oral ferric maltol treatment resulted in significantly increased
haemoglobin (from 11.4  10.9-11.9  to 12.8  11.8-13.8  g/dl) from baseline to
week 16 (p<0.001).

·    Statistically significant differences from baseline to week 16 in
6-minute walk test (6MW) (p<0.001) and Quality of Life scores (p=0.004)

o  Oral ferric maltol treatment resulted in significant increase in distance
walked in 6MW test (from 298  220-405  to 335  255-430  meters).

o  Oral ferric maltol treatment resulted in a significant increase in the
Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (from 65
 44-82  to 76  55-86  score points).

·    Statistically significant differences from baseline to week 16 in
Other Iron Markers (ferritin, iron, transferrin saturation) (p<0.001)

·    Ferric maltol was well-tolerated with no serious related adverse
events reported

o  Adverse event profiles were consistent with previous Phase 3 studies.

o  AEs (N=19) were mainly GI related.

 

These positive results published in the European Journal of Heart Failure
(Oral ferric maltol improves iron deficiency anaemia in patients with chronic
heart failure - Kempf - European Journal of Heart Failure - Wiley Online
Library (https://onlinelibrary.wiley.com/doi/10.1002/ejhf.3789) , ) are
consistent with results reported from an earlier study in patients with
pulmonary hypertension (PH) and anemia published in the European Respiratory
Society (Oral iron supplementation with ferric maltol in patients with
pulmonary hypertension | European Respiratory Society
(https://publications.ersnet.org/content/erj/56/5/2000616) ).

 

Shield's licensing partner in Japan (VITAL-NET, Inc. (VITAL-NET)) has recently
had an IND approved to further investigate the impact of ferric maltol
treatment in Japanese patients with PH and anemia in Japan.

 

Professor Johann Bauersachs, Director of the Department of Cardiology and
Angiology at Hannover Medical School, and lead author of the HF publication,
said: "We still have a significant clinical unmet need for an effective and
well tolerated oral iron therapy for the treatment of heart failure. Ferric
maltol could be the practicable oral alternative to intravenous therapy for
the treatment of heart failure reducing the challenges of i.v therapy."

 

Anders Lundstrom, CEO, Shield Therapeutics commented: "We are delighted that
we once again have clinically and statistically relevant results in new
patient populations for ACCRUFeR®/FeRACCRU® and we are excited that our
partner, VITAL-NET will further investigate this important new therapeutic
area where ferric maltol promises to bring significant clinical benefit."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel                                                                                    +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for adults of all ages, across multiple therapeutic areas. Together,
ID and ID with anemia (IDA) affect about 20 million people in the US and
represent a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet
medical need for both physicians and patients.

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. The drug has a novel mechanism of absorption
compared to other oral iron therapies and has been shown to be an efficacious
and well-tolerated therapy in a range of clinical trials. More information
about ACCRUFeR®/FeRACCRU®, including the product label, can be found at:
www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration
agreement with Viatris. Outside of the U.S., the Company has licensed the
rights to five specialty pharmaceutical companies. FeRACCRU® is
commercialised in the UK and European Union by Norgine B.V., which also has
marketing rights in Australia and New Zealand. Shield also has an exclusive
license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the
development and commercialisation of ACCRUFeR®/FeRACCRU® in China, Hong
Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea,
with Kye Pharmaceuticals Inc. for Canada, and with VITAL-NET for Japan.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

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