REG - Shield Therapeutics - ACCRUFeR Pediatric PK Results to be Presented

Shield TherapeuticsAnnouncement

Tue 07:00

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RNS Number : 9586G  Shield Therapeutics PLC  11 November 2025

  Shield Therapeutics plc

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

 

ACCRUFeR® Pediatric Pharmacokinetic (PK) Results Will be Presented at the
American Society of Hematology (ASH) Conference

 

Results from PK Sub study of Positive Phase 3 Pediatric Trial (FORTIS)
confirmed ferric maltol's suitability for iron replacement in children 1 month
and above

 

London, UK, 11 November 2025 Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency, today
announced the presentation (Abstract/Video and in person Poster) of a PK study
(conducted as a sub-study of the positive FORTIS efficacy, tolerability and
palatability pediatric ferric maltol clinical trial) at the American Society
of Hematology (ASH) National Conference on 06 December 2025 in Orlando,
Florida.

 

Abstract available online via the ASH Conference website: ASH 2025 Annual
Meeting - Presentation
(https://submit.hematology.org/program/presentation/671764)

 

Abstract/Poster Details:

Title:                     Presentation ID 1126:
Pharmacokinetics of ferric maltol oral suspension in children and adolescents
(1 month to 17 years); A study of iron and maltol metabolism following single
and multiple dosing

 

Presenter:          Dr Andrew Freiberg MD (Associate Professor of
Pediatrics, Penn State Health, Pennsylvania, United States)

 

Key Results:

·    The PK profile in children and adolescents demonstrated ferric
maltol's suitability for iron replacement in all age groups

·    Iron was well-absorbed at the age-appropriate doses used in the Phase
3 study

·    Maltol was rapidly metabolised and excreted in the urine with no
accumulation in any age group

·    First data that confirms maltol metabolism and rapid excretion in the
urine in infants 1 month to less than 2 years

The FORTIS study, including the PK data, is pivotal in supporting the Clinical
Supplement assigned Priority Review by the US FDA to extend the indication for
ACCRUFeR® to include adolescents aged 10 years and above.

 

Dr Jackie Mitchell, VP of Quality, RA and Clinical Development at Shield,
commented: "This first publication of results confirming effective iron
absorption and maltol metabolism in children as young as 1 month supports the
potential use of ferric maltol as an effective iron-replacement therapy in
infants as well as older children, and is an important milestone for Shield in
the expansion of ACCRUFeR® to an infant population where there is an unmet
need for a 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 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 the FORTIS/ST10-01-305 Phase 3 study and PK Sub-study

The FORTIS study compared the safety, tolerability and effectiveness of an
oral liquid suspension of ferric maltol with oral ferrous sulphate liquid in
children with iron deficiency anaemia (IDA).The open label randomized Phase 3
study included children aged 1 month to 17 years with mild to moderate IDA,
who also had serum ferritin levels below 30 μg/L or ferritin levels below 50
μg/L and transferrin saturation below 20%.  Children aged 2 to 17 years were
randomized 1:1 to receive either ferric maltol (N=31) or ferrous sulphate (N =
30).  Children 1 months to under 2 years (N=4) were all assigned to receive
ferric maltol treatment. The composite primary endpoints were:

·    Frequency of treatment emergent adverse events (TEAEs)/serious
adverse events (TESAEs)

·    Frequency of discontinuations from the study as a result of TEAEs

·    Change in haemoglobin (Hb) concentration from baseline to week 12

Twenty children (2-17 years) participated in the PK study over two assessment
days (Day 1 & Day 7-10). On Day 1, after a baseline blood sample, they
received a single supervised ferric maltol dose (iron equivalent at 15mg or
30mg doses), followed by PK. Then, twice-daily (BID) dosing of the same dosage
continued until Day 7-10, when the morning dose was withheld, and the PK
procedure was repeated.  Three infants (aged 1 month to < 2 years
completed a one-day PK assessment with a single 0.6 mg/kg iron equivalent dose
of ferric maltol. Urine samples collected over 12 hours were analyzed for
maltol metabolism. If no accumulation of maltol or its metabolites was found,
0.6mg/kg BID dosing continued for 7-10 days. On Day 7-10, after baseline
sampling, the same dose was given, followed by PK blood sampling (1-12 hours)
and urine collection (0.5-12 hours). PK blood samples were evaluated for
plasma maltol and maltol glucuronide levels and serum iron.

 

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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