REG - Shield Therapeutics - Positive efficacy and tolerance in pediatric trial

Shield TherapeuticsAnnouncement

Wed 07:02

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RNS Number : 5065B  Shield Therapeutics PLC  01 October 2025

  Shield Therapeutics plc

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

 

ACCRUFeR® Phase 3 pediatric trial presentation at the American Association of
Pediatrics (AAP) Conference

 

Positive efficacy and tolerance in pediatric trial (FORTIS)

 

 

London, UK, 01 October 2025 Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency, today
announced the presentation (virtual and in person) of the positive efficacy,
tolerability and palatability results for the ferric maltol pediatric FORTIS
clinical trial at the American Association of Pediatrics (AAP) National
Conference on 29(th) September 2025 in Denver, Colorado.

 

Abstract available online via the AAP Conference website: Browse Poster Hall
(https://aapexperience25.eventscribe.net/searchbyposterbucket.asp?f=PosterCustomField34&pfp=BrowsePosterHall)

 

The Poster can be viewed via the Shield website: Publications | Shield
Therapeutics plc (https://www.shieldtherapeutics.com/products/publications/)

 

Poster Presentation Details:

Title:                    P4.017: "Efficacy And Safety Of A Novel
Oral Iron (Ferric Maltol) In Children And Adolescents; A Randomized,
Multicenter, Open-Label, Active Comparator Study"

Presenter:          Dr David Gass MD MS (Associate professor of
pediatrics. Carolinas Medical Centre, Charlotte)

 

Key Results (as previously disclosed):

·    Clinically and statistically significant Hb improvements vs. baseline
were observed across all groups (ferric maltol arms and ferrous sulfate arm
(P<0.0001)

·   No patient discontinued ferric maltol treatment due to an adverse event
compared to one patient who discontinued from the ferrous sulfate arm.

·    Treatment related adverse events (AEs) were reported in 6.5% of
patients treated with ferric maltol and 13% of patients treated with ferrous
sulphate.  No treatment related serious AEs (SAEs) were reported in either
group.

 

Dr Jackie Mitchell, VP of Quality, RA and Clinical Development at Shield,
commented: "This first publication of results confirming the safety and
effectiveness of ferric maltol treatment in children as young as 2 months is
an important milestone for Shield to further the expansion of ACCRUFeR® in
this additional patient population who can benefit from a much needed safe and
effective oral iron treatment."

 

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 and is now the leading #1
branded prescription oral iron in the market today (data source - IQVIA
Xponent PlanTrak).

 

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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